<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01660399</url>
  </required_header>
  <id_info>
    <org_study_id>CIH-CHP-201205001</org_study_id>
    <nct_id>NCT01660399</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Boanmycin Hydrochloride With Docetaxel for Patients With Lung Squamous Cell Cancer as Chemotherapy</brief_title>
  <official_title>Boanmycin Hydrochloride for Injection in Combination With Docetaxel for Patients With Advanced Lung Squamous Cell Carcinoma as Salvage Chemotherapy: a Prospective, Randomized, Parallel and Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This predictive, randomized, double-blind, multi-center trial is going to evaluate the&#xD;
      efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a&#xD;
      second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous&#xD;
      cell lung cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At present, there is no reliable second line treatment except chemotherapy for squamous cell&#xD;
      carcinoma patients, the current chemotherapy regimen, including docetaxel as a single agent&#xD;
      which is known as the gold standard, the weekly using of docetaxel and the combination of&#xD;
      EGFR-TKI has few evidence for high response rates and prolonged survival.On the other hand,&#xD;
      the adverse reaction of chemotherapy makes the combined chemotherapy cannot improve&#xD;
      therapeutic effects. Boanmycin with special pharmacological basis, as well as the high&#xD;
      purity, may not obvious increase in adverse reactions, and probably improve the effect of&#xD;
      chemotherapy. At the same time, because of its low lung toxicity, especially in the combined&#xD;
      use of corticosteroids, and in the background of the poor survival of advanced squamous cell&#xD;
      lung cancer patients, the chemotherapy regimen of boanmycin plus docetaxel needs to be&#xD;
      investigated.&#xD;
&#xD;
      This predictive, randomized, double-blind, multi-center trial is going to evaluate the&#xD;
      efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a&#xD;
      second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous&#xD;
      cell lung cancer patients.&#xD;
&#xD;
      According to the test center, gender, disease staging (stage IIIB, IV/recurrence) and&#xD;
      pathologic types, patients with squamous cell lung cancer were stratified and then randomly&#xD;
      assigned to one of two groups. In the first group, 75 mg of docetaxel per square meter of&#xD;
      body-surface area, administered on day 1, followed by 5~6 mg boanmycin of per square meter&#xD;
      and 5mg dexamethasone on days 3,5,10 and 12, the cycle was repeated every 21days. The second&#xD;
      group received the reference treatment: docetaxel at a dose of 75 mg per square meter was&#xD;
      administered on on day 1 of a three-week cycle. The efficacy was evaluated using RESIST&#xD;
      standard after every 2 cycles of the treatment, the regimen will continue until the disease&#xD;
      progression or the appearance of not tolerable toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease free survival</measure>
    <time_frame>1.5 years</time_frame>
    <description>DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>1.5 years</time_frame>
    <description>OS was defined as the length of time from the date of randomization to the date of death of various reasons.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1.5 years</time_frame>
    <description>An Adverse Events is any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>serious adverse event</measure>
    <time_frame>1.5 years</time_frame>
    <description>SAE is medically significant or requires intervention to prevent one or other of the outcomes, such as: Fatal (results in death);Life-Threatening Hospitalization; prolong hospitalization; Anomaly/birth defect or Disability/incapacity.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Squamous Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Docetaxel/Boanmycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Docetaxel 75mg/m2, intravenous infusion, day 1; Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Docetaxel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Docetaxel 75mg/m2, intravenous infusion, day 1, 21days a cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Boanmycin</intervention_name>
    <description>Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.</description>
    <arm_group_label>Docetaxel/Boanmycin</arm_group_label>
    <other_name>Boanmycin Hydrochloride for Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Docetaxel 75mg/m2, intravenous infusion, day 1.</description>
    <arm_group_label>Docetaxel</arm_group_label>
    <arm_group_label>Docetaxel/Boanmycin</arm_group_label>
    <other_name>Docetaxel for Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically or cytology confirmed III，IV or after operation recurrent squamous cell&#xD;
             lung cancer;&#xD;
&#xD;
          -  disease progressed after first-line chemotherapy and not suitable for EGFR-TKI;&#xD;
&#xD;
          -  no radiotherapy for metastases outside the lung 4 weeks before;&#xD;
&#xD;
          -  the lesions are measurable in CT images and are measured follow criteria RECIST 1.1 2&#xD;
             weeks before randomization;&#xD;
&#xD;
          -  ECOG scale 0-1, expected survival&gt;3 month;&#xD;
&#xD;
          -  white blood count ≥ 3,500/mm3, absolute neutrophil≥ 1,500/mm3, platelet count ≥&#xD;
             100,000/mm3, hemoglobin count≥ 90 g/dL；serum bilirubin level ≤ 1.5 of the upper limit&#xD;
             of normal(ULN) for the institution, aspartate aminotransferase, alanine&#xD;
             aminotransferase and alkaline phosphatase≤ 2.5 ULN, serum creatinine≤ 1.5 ULN;&#xD;
&#xD;
          -  with good compliance；&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  past history of major operation in 4 weeks;&#xD;
&#xD;
          -  involved in other clinical trials in 4 weeks;&#xD;
&#xD;
          -  past history of central nervous system or relevant disease except for well-controlled&#xD;
             CNS metastasis;&#xD;
&#xD;
          -  past history of other cancers except for cured non-melanoma skin cancer or cervical&#xD;
             cancer;&#xD;
&#xD;
          -  concomitant treatment with other anticancer drugs.&#xD;
&#xD;
          -  pregnancy, breast feeding or fertility but not taking contraceptive device during the&#xD;
             trials;&#xD;
&#xD;
          -  radiotherapy for target lesions in lung;&#xD;
&#xD;
          -  clear TKI-related mutation in EGFR;&#xD;
&#xD;
          -  with severe heart disease, hypertension, diabetes mellitus or active infection.&#xD;
&#xD;
          -  past history of allergy to taxanes;&#xD;
&#xD;
          -  past history of severe acute or chronic kidney disease;&#xD;
&#xD;
          -  active hepatitis b or HIV positive patients;&#xD;
&#xD;
          -  cannot tolerate Corticosteroid;&#xD;
&#xD;
          -  past history of COPD or other critical basic pulmonary diseases;&#xD;
&#xD;
          -  history of severe mental illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peng Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peng Chen, M.D.</last_name>
    <phone>+86-13702152241</phone>
    <email>chenpengdoc@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peng Chen, M.D.</last_name>
      <phone>+86-22-23340123</phone>
      <phone_ext>3206</phone_ext>
      <email>chenpengdoc@sina.com</email>
    </contact>
    <investigator>
      <last_name>Peng Chen, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.</citation>
    <PMID>7580546</PMID>
  </results_reference>
  <results_reference>
    <citation>Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.</citation>
    <PMID>11784875</PMID>
  </results_reference>
  <results_reference>
    <citation>Socinski MA, Schell MJ, Peterman A, Bakri K, Yates S, Gitten R, Unger P, Lee J, Lee JH, Tynan M, Moore M, Kies MS. Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer. J Clin Oncol. 2002 Mar 1;20(5):1335-43. doi: 10.1200/JCO.2002.20.5.1335.</citation>
    <PMID>11870177</PMID>
  </results_reference>
  <results_reference>
    <citation>Buter J, Giaccone G. EGFR inhibitors in lung cancer. Oncology (Williston Park). 2005 Nov;19(13):1707-11; discussion 1711-2, 1720-3.</citation>
    <PMID>16425523</PMID>
  </results_reference>
  <results_reference>
    <citation>Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884. Erratum In: N Engl J Med. 2007 Jan 18;356(3):318.</citation>
    <PMID>17167137</PMID>
  </results_reference>
  <results_reference>
    <citation>Eberhard DA, Johnson BE, Amler LC, Goddard AD, Heldens SL, Herbst RS, Ince WL, Janne PA, Januario T, Johnson DH, Klein P, Miller VA, Ostland MA, Ramies DA, Sebisanovic D, Stinson JA, Zhang YR, Seshagiri S, Hillan KJ. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol. 2005 Sep 1;23(25):5900-9. doi: 10.1200/JCO.2005.02.857. Epub 2005 Jul 25.</citation>
    <PMID>16043828</PMID>
  </results_reference>
  <results_reference>
    <citation>Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.</citation>
    <PMID>19410716</PMID>
  </results_reference>
  <results_reference>
    <citation>Fossella FV, Lee JS, Shin DM, Calayag M, Huber M, Perez-Soler R, Murphy WK, Lippman S, Benner S, Glisson B, et al. Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer. J Clin Oncol. 1995 Mar;13(3):645-51. doi: 10.1200/JCO.1995.13.3.645.</citation>
    <PMID>7884425</PMID>
  </results_reference>
  <results_reference>
    <citation>Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000 May;18(10):2095-103. doi: 10.1200/JCO.2000.18.10.2095.</citation>
    <PMID>10811675</PMID>
  </results_reference>
  <results_reference>
    <citation>MA Jinlan, FENG Fengyi, ZHOU Liqiang, SUN Yan.Pharmacokinetics Study and Clinical Evaluation on Boanmycin.China Pharmacy 16(17):1314-1315, 2005.</citation>
  </results_reference>
  <results_reference>
    <citation>Wang Ping hui, Liu Liping, Hou Yuanshu et al.Phase II Clinical Trial of The New Anticancer Drug-Boanmycin.Chinese Journal of Clinical Oncology 25(9):657-659, 1998.</citation>
  </results_reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>December 21, 2015</last_update_submitted>
  <last_update_submitted_qc>December 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>salvage chemotherapy</keyword>
  <keyword>advanced squamous cell lung cancer</keyword>
  <keyword>Boanmycin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01660399
org study id: CIH-CHP-201205001
nct id: NCT01660399
lead sponsor: 
has dmc: Yes
This predictive, randomized, double-blind, multi-center trial is going to evaluate the
      efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a
      second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous
      cell lung cancer patients.
At present, there is no reliable second line treatment except chemotherapy for squamous cell
      carcinoma patients, the current chemotherapy regimen, including docetaxel as a single agent
      which is known as the gold standard, the weekly using of docetaxel and the combination of
      EGFR-TKI has few evidence for high response rates and prolonged survival.On the other hand,
      the adverse reaction of chemotherapy makes the combined chemotherapy cannot improve
      therapeutic effects. Boanmycin with special pharmacological basis, as well as the high
      purity, may not obvious increase in adverse reactions, and probably improve the effect of
      chemotherapy. At the same time, because of its low lung toxicity, especially in the combined
      use of corticosteroids, and in the background of the poor survival of advanced squamous cell
      lung cancer patients, the chemotherapy regimen of boanmycin plus docetaxel needs to be
      investigated.

      This predictive, randomized, double-blind, multi-center trial is going to evaluate the
      efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a
      second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous
      cell lung cancer patients.

      According to the test center, gender, disease staging (stage IIIB, IV/recurrence) and
      pathologic types, patients with squamous cell lung cancer were stratified and then randomly
      assigned to one of two groups. In the first group, 75 mg of docetaxel per square meter of
      body-surface area, administered on day 1, followed by 5~6 mg boanmycin of per square meter
      and 5mg dexamethasone on days 3,5,10 and 12, the cycle was repeated every 21days. The second
      group received the reference treatment: docetaxel at a dose of 75 mg per square meter was
      administered on on day 1 of a three-week cycle. The efficacy was evaluated using RESIST
      standard after every 2 cycles of the treatment, the regimen will continue until the disease
      progression or the appearance of not tolerable toxicity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: disease free survival
time frame: 1.5 years
description: DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
measure: overall survival
time frame: 1.5 years
description: OS was defined as the length of time from the date of randomization to the date of death of various reasons.
measure: Adverse Events
time frame: 1.5 years
description: An Adverse Events is any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
measure: serious adverse event
time frame: 1.5 years
description: SAE is medically significant or requires intervention to prevent one or other of the outcomes, such as: Fatal (results in death);Life-Threatening Hospitalization; prolong hospitalization; Anomaly/birth defect or Disability/incapacity.
arm group label: Docetaxel/Boanmycin
arm group type: Experimental
description: Docetaxel 75mg/m2, intravenous infusion, day 1; Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.
arm group label: Docetaxel
arm group type: Placebo Comparator
description: Docetaxel 75mg/m2, intravenous infusion, day 1, 21days a cycle.
intervention type: Drug
intervention name: Boanmycin
description: Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.
arm group label: Docetaxel/Boanmycin
other name: Boanmycin Hydrochloride for Injection
intervention type: Drug
intervention name: Docetaxel
description: Docetaxel 75mg/m2, intravenous infusion, day 1.
arm group label: Docetaxel
arm group label: Docetaxel/Boanmycin
other name: Docetaxel for Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peng Chen, M.D.
role: Principal Investigator
affiliation: Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
last name: Peng Chen, M.D.
phone: +86-13702152241
email: chenpengdoc@sina.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.
PMID: 7580546
citation: Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
PMID: 11784875
citation: Socinski MA, Schell MJ, Peterman A, Bakri K, Yates S, Gitten R, Unger P, Lee J, Lee JH, Tynan M, Moore M, Kies MS. Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer. J Clin Oncol. 2002 Mar 1;20(5):1335-43. doi: 10.1200/JCO.2002.20.5.1335.
PMID: 11870177
citation: Buter J, Giaccone G. EGFR inhibitors in lung cancer. Oncology (Williston Park). 2005 Nov;19(13):1707-11; discussion 1711-2, 1720-3.
PMID: 16425523
citation: Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884. Erratum In: N Engl J Med. 2007 Jan 18;356(3):318.
PMID: 17167137
citation: Eberhard DA, Johnson BE, Amler LC, Goddard AD, Heldens SL, Herbst RS, Ince WL, Janne PA, Januario T, Johnson DH, Klein P, Miller VA, Ostland MA, Ramies DA, Sebisanovic D, Stinson JA, Zhang YR, Seshagiri S, Hillan KJ. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol. 2005 Sep 1;23(25):5900-9. doi: 10.1200/JCO.2005.02.857. Epub 2005 Jul 25.
PMID: 16043828
citation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.
PMID: 19410716
citation: Fossella FV, Lee JS, Shin DM, Calayag M, Huber M, Perez-Soler R, Murphy WK, Lippman S, Benner S, Glisson B, et al. Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer. J Clin Oncol. 1995 Mar;13(3):645-51. doi: 10.1200/JCO.1995.13.3.645.
PMID: 7884425
citation: Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000 May;18(10):2095-103. doi: 10.1200/JCO.2000.18.10.2095.
PMID: 10811675
citation: MA Jinlan, FENG Fengyi, ZHOU Liqiang, SUN Yan.Pharmacokinetics Study and Clinical Evaluation on Boanmycin.China Pharmacy 16(17):1314-1315, 2005.
citation: Wang Ping hui, Liu Liping, Hou Yuanshu et al.Phase II Clinical Trial of The New Anticancer Drug-Boanmycin.Chinese Journal of Clinical Oncology 25(9):657-659, 1998.
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Docetaxel