<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/NCT02993705</url>
  </required_header>
  <id_info>
    <org_study_id>1561</org_study_id>
    <nct_id>NCT02993705</nct_id>
  </id_info>
  <brief_title>Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)</brief_title>
  <acronym>MITO 26</acronym>
  <official_title>Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter phase II study on trabectedin in patients advanced uterine and ovarian&#xD;
      carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable&#xD;
      toxicity. Disease response evaluation will be assessed every 9 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity&#xD;
      of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.&#xD;
&#xD;
      Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks&#xD;
      via a central venous catheter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">November 13, 2019</completion_date>
  <primary_completion_date type="Actual">November 13, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>three years</time_frame>
    <description>The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>three years</time_frame>
    <description>the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>three years</time_frame>
    <description>Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Carcinosarcoma, Ovarian</condition>
  <condition>Carcinosarcomas Uterine</condition>
  <arm_group>
    <arm_group_label>Trabectedin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trabectedin</intervention_name>
    <description>Chemotherapy drug</description>
    <arm_group_label>Trabectedin</arm_group_label>
    <other_name>Yondelis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma&#xD;
             not amenable to surgery or radiotherapy&#xD;
&#xD;
          -  No more than 2 previous chemotherapy lines&#xD;
&#xD;
          -  PS 0-2 (ECOG)&#xD;
&#xD;
          -  Age&gt; 18&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
&#xD;
          -  Adequate organ functions:&#xD;
&#xD;
               -  Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥&#xD;
                  100,000/mm^3; Hemoglobin ≥ 9 g/dL Hepatic; AST and ALT ≤ 1.5 times upper limit of&#xD;
                  normal (ULN)*; Protocol Version 1.0_05.09.2016 6 Alkaline phosphatase ≤ 2.5 times&#xD;
                  ULN*; Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 3 times ULN if liver metastases are&#xD;
                  present Renal; Creatinine Clearance ≥ 45 mL/min or Serum Creatinine ≤1.5 x ULN&#xD;
                  Serum Albumin &gt;3.0 g/dL&#xD;
&#xD;
          -  Previous Brachytherapy treatment for uterine carcinosarcoma is allowed&#xD;
&#xD;
          -  No other invasive malignancy within the past 3 years except non-melanoma skin cancer&#xD;
&#xD;
          -  Written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 2 previous chemotherapy lines&#xD;
&#xD;
          -  Single tumor lesion inside a previous irradiated filed&#xD;
&#xD;
          -  Pregnant (potentially fertile patients must be not in pregnancy during and for at&#xD;
             least 3 months after study participation and must have a negative serum pregnancy&#xD;
             test)&#xD;
&#xD;
          -  Active infection requiring antibiotics&#xD;
&#xD;
          -  Symptomatic peripheral neuropathy &gt; grade 2 according to the NCI Common Toxicity&#xD;
             Criteria.&#xD;
&#xD;
          -  Congestive heart failure or angina pectoris even if it is medically controlled.&#xD;
             Previous history of myocardial infarction within 1 year from study entry, uncontrolled&#xD;
             high risk hypertension or arrhythmia.&#xD;
&#xD;
          -  Unstable or severe intercurrent medical condition that, in the opinion of the&#xD;
             investigator, might interfere with achievement of study objectives&#xD;
&#xD;
          -  Psychological or sociological conditions, addictive disorders, or family problems,&#xD;
             which would preclude compliance with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Domenica Lorusso, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Policlinico Universitario A. Gemelli, IRCCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Schoffski P, Casali PP, Taron M, et al. Impact of the DNA repair functionality on the outcome of sarcoma patients treated with trabectedin (ET-743). J Clin Oncol, 2006; 24 (18 Suppl):525s (Abstract#9522)</citation>
  </reference>
  <results_reference>
    <citation>Berton-Rigaud D, Devouassoux-Shisheboran M, Ledermann JA, Leitao MM, Powell MA, Poveda A, Beale P, Glasspool RM, Creutzberg CL, Harter P, Kim JW, Reed NS, Ray-Coquard I. Gynecologic Cancer InterGroup (GCIG) consensus review for uterine and ovarian carcinosarcoma. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S55-60. doi: 10.1097/IGC.0000000000000228.</citation>
    <PMID>25341582</PMID>
  </results_reference>
  <results_reference>
    <citation>Makker V, Abu-Rustum NR, Alektiar KM, Aghajanian CA, Zhou Q, Iasonos A, Hensley ML. A retrospective assessment of outcomes of chemotherapy-based versus radiation-only adjuvant treatment for completely resected stage I-IV uterine carcinosarcoma. Gynecol Oncol. 2008 Nov;111(2):249-54. doi: 10.1016/j.ygyno.2008.06.035. Epub 2008 Aug 27.</citation>
    <PMID>18755503</PMID>
  </results_reference>
  <results_reference>
    <citation>Cicin I, Saip P, Eralp Y, Selam M, Topuz S, Ozluk Y, Aydin Y, Topuz E. Ovarian carcinosarcomas: clinicopathological prognostic factors and evaluation of chemotherapy regimens containing platinum. Gynecol Oncol. 2008 Jan;108(1):136-40. doi: 10.1016/j.ygyno.2007.09.003. Epub 2007 Oct 23.</citation>
    <PMID>17936342</PMID>
  </results_reference>
  <results_reference>
    <citation>Jonson AL, Bliss RL, Truskinovsky A, Judson P, Argenta P, Carson L, Dusenbery K, Downs LS Jr. Clinical features and outcomes of uterine and ovarian carcinosarcoma. Gynecol Oncol. 2006 Mar;100(3):561-4. doi: 10.1016/j.ygyno.2005.09.017. Epub 2005 Nov 4.</citation>
    <PMID>16271748</PMID>
  </results_reference>
  <results_reference>
    <citation>Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2. Erratum In: Eur J Cancer. 2008 Jul;44(11):1612.</citation>
    <PMID>18378136</PMID>
  </results_reference>
  <results_reference>
    <citation>Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. doi: 10.1016/j.ygyno.2007.07.070. Epub 2007 Sep 5.</citation>
    <PMID>17822748</PMID>
  </results_reference>
  <results_reference>
    <citation>Sutton G, Brunetto VL, Kilgore L, Soper JT, McGehee R, Olt G, Lentz SS, Sorosky J, Hsiu JG. A phase III trial of ifosfamide with or without cisplatin in carcinosarcoma of the uterus: A Gynecologic Oncology Group Study. Gynecol Oncol. 2000 Nov;79(2):147-53. doi: 10.1006/gyno.2000.6001.</citation>
    <PMID>11063636</PMID>
  </results_reference>
  <results_reference>
    <citation>Sutton G, Kauderer J, Carson LF, Lentz SS, Whitney CW, Gallion H; Gynecologic Oncology Group. Adjuvant ifosfamide and cisplatin in patients with completely resected stage I or II carcinosarcomas (mixed mesodermal tumors) of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):630-4. doi: 10.1016/j.ygyno.2004.11.022.</citation>
    <PMID>15721404</PMID>
  </results_reference>
  <results_reference>
    <citation>Toyoshima M, Akahira J, Matsunaga G, Niikura H, Ito K, Yaegashi N, Tase T. Clinical experience with combination paclitaxel and carboplatin therapy for advanced or recurrent carcinosarcoma of the uterus. Gynecol Oncol. 2004 Sep;94(3):774-8. doi: 10.1016/j.ygyno.2004.05.048.</citation>
    <PMID>15350372</PMID>
  </results_reference>
  <results_reference>
    <citation>Leiser AL, Chi DS, Ishill NM, Tew WP. Carcinosarcoma of the ovary treated with platinum and taxane: the memorial Sloan-Kettering Cancer Center experience. Gynecol Oncol. 2007 Jun;105(3):657-61. doi: 10.1016/j.ygyno.2007.01.037. Epub 2007 Mar 28.</citation>
    <PMID>17395252</PMID>
  </results_reference>
  <results_reference>
    <citation>Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 10;25(5):526-31. doi: 10.1200/JCO.2006.06.4907.</citation>
    <PMID>17290061</PMID>
  </results_reference>
  <results_reference>
    <citation>Takebayashi Y, Pourquier P, Zimonjic DB, Nakayama K, Emmert S, Ueda T, Urasaki Y, Kanzaki A, Akiyama SI, Popescu N, Kraemer KH, Pommier Y. Antiproliferative activity of ecteinascidin 743 is dependent upon transcription-coupled nucleotide-excision repair. Nat Med. 2001 Aug;7(8):961-6. doi: 10.1038/91008. Erratum In: Nat Med 2001 Nov;7(11):1255.</citation>
    <PMID>11479630</PMID>
  </results_reference>
  <results_reference>
    <citation>Damia G, Silvestri S, Carrassa L, Filiberti L, Faircloth GT, Liberi G, Foiani M, D'Incalci M. Unique pattern of ET-743 activity in different cellular systems with defined deficiencies in DNA-repair pathways. Int J Cancer. 2001 May 15;92(4):583-8. doi: 10.1002/ijc.1221.</citation>
    <PMID>11304695</PMID>
  </results_reference>
  <results_reference>
    <citation>Germano G, Frapolli R, Belgiovine C, Anselmo A, Pesce S, Liguori M, Erba E, Uboldi S, Zucchetti M, Pasqualini F, Nebuloni M, van Rooijen N, Mortarini R, Beltrame L, Marchini S, Fuso Nerini I, Sanfilippo R, Casali PG, Pilotti S, Galmarini CM, Anichini A, Mantovani A, D'Incalci M, Allavena P. Role of macrophage targeting in the antitumor activity of trabectedin. Cancer Cell. 2013 Feb 11;23(2):249-62. doi: 10.1016/j.ccr.2013.01.008.</citation>
    <PMID>23410977</PMID>
  </results_reference>
  <results_reference>
    <citation>del Campo JM, Sessa C, Krasner CN, Vermorken JB, Colombo N, Kaye S, Gore M, Zintl P, Gomez J, Parekh T, Park YC, McMeekin S. Trabectedin as single agent in relapsed advanced ovarian cancer: results from a retrospective pooled analysis of three phase II trials. Med Oncol. 2013 Mar;30(1):435. doi: 10.1007/s12032-012-0435-1. Epub 2013 Feb 9.</citation>
    <PMID>23397080</PMID>
  </results_reference>
  <results_reference>
    <citation>Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.</citation>
    <PMID>10655437</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinosarcoma</mesh_term>
    <mesh_term>Mixed Tumor, Mullerian</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trabectedin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02993705
org study id: 1561
nct id: NCT02993705
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multicenter phase II study on trabectedin in patients advanced uterine and ovarian
      carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable
      toxicity. Disease response evaluation will be assessed every 9 weeks.
This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity
      of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.

      Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks
      via a central venous catheter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: three years
description: The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.
measure: Duration of response
time frame: three years
measure: Progression Free Survival (PFS)
time frame: three years
description: the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression
measure: Overall Survival (OS)
time frame: three years
measure: Adverse events
time frame: three years
description: Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.
arm group label: Trabectedin
arm group type: Experimental
description: Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.
intervention type: Drug
intervention name: Trabectedin
description: Chemotherapy drug
arm group label: Trabectedin
other name: Yondelis
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Domenica Lorusso, Prof.
role: Principal Investigator
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
facility: 
country: Italy
citation: Schoffski P, Casali PP, Taron M, et al. Impact of the DNA repair functionality on the outcome of sarcoma patients treated with trabectedin (ET-743). J Clin Oncol, 2006; 24 (18 Suppl):525s (Abstract#9522)
citation: Berton-Rigaud D, Devouassoux-Shisheboran M, Ledermann JA, Leitao MM, Powell MA, Poveda A, Beale P, Glasspool RM, Creutzberg CL, Harter P, Kim JW, Reed NS, Ray-Coquard I. Gynecologic Cancer InterGroup (GCIG) consensus review for uterine and ovarian carcinosarcoma. Int J Gynecol Cancer. 2014 Nov;24(9 Suppl 3):S55-60. doi: 10.1097/IGC.0000000000000228.
PMID: 25341582
citation: Makker V, Abu-Rustum NR, Alektiar KM, Aghajanian CA, Zhou Q, Iasonos A, Hensley ML. A retrospective assessment of outcomes of chemotherapy-based versus radiation-only adjuvant treatment for completely resected stage I-IV uterine carcinosarcoma. Gynecol Oncol. 2008 Nov;111(2):249-54. doi: 10.1016/j.ygyno.2008.06.035. Epub 2008 Aug 27.
PMID: 18755503
citation: Cicin I, Saip P, Eralp Y, Selam M, Topuz S, Ozluk Y, Aydin Y, Topuz E. Ovarian carcinosarcomas: clinicopathological prognostic factors and evaluation of chemotherapy regimens containing platinum. Gynecol Oncol. 2008 Jan;108(1):136-40. doi: 10.1016/j.ygyno.2007.09.003. Epub 2007 Oct 23.
PMID: 17936342
citation: Jonson AL, Bliss RL, Truskinovsky A, Judson P, Argenta P, Carson L, Dusenbery K, Downs LS Jr. Clinical features and outcomes of uterine and ovarian carcinosarcoma. Gynecol Oncol. 2006 Mar;100(3):561-4. doi: 10.1016/j.ygyno.2005.09.017. Epub 2005 Nov 4.
PMID: 16271748
citation: Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2. Erratum In: Eur J Cancer. 2008 Jul;44(11):1612.
PMID: 18378136
citation: Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. doi: 10.1016/j.ygyno.2007.07.070. Epub 2007 Sep 5.
PMID: 17822748
citation: Sutton G, Brunetto VL, Kilgore L, Soper JT, McGehee R, Olt G, Lentz SS, Sorosky J, Hsiu JG. A phase III trial of ifosfamide with or without cisplatin in carcinosarcoma of the uterus: A Gynecologic Oncology Group Study. Gynecol Oncol. 2000 Nov;79(2):147-53. doi: 10.1006/gyno.2000.6001.
PMID: 11063636
citation: Sutton G, Kauderer J, Carson LF, Lentz SS, Whitney CW, Gallion H; Gynecologic Oncology Group. Adjuvant ifosfamide and cisplatin in patients with completely resected stage I or II carcinosarcomas (mixed mesodermal tumors) of the uterus: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):630-4. doi: 10.1016/j.ygyno.2004.11.022.
PMID: 15721404
citation: Toyoshima M, Akahira J, Matsunaga G, Niikura H, Ito K, Yaegashi N, Tase T. Clinical experience with combination paclitaxel and carboplatin therapy for advanced or recurrent carcinosarcoma of the uterus. Gynecol Oncol. 2004 Sep;94(3):774-8. doi: 10.1016/j.ygyno.2004.05.048.
PMID: 15350372
citation: Leiser AL, Chi DS, Ishill NM, Tew WP. Carcinosarcoma of the ovary treated with platinum and taxane: the memorial Sloan-Kettering Cancer Center experience. Gynecol Oncol. 2007 Jun;105(3):657-61. doi: 10.1016/j.ygyno.2007.01.037. Epub 2007 Mar 28.
PMID: 17395252
citation: Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 10;25(5):526-31. doi: 10.1200/JCO.2006.06.4907.
PMID: 17290061
citation: Takebayashi Y, Pourquier P, Zimonjic DB, Nakayama K, Emmert S, Ueda T, Urasaki Y, Kanzaki A, Akiyama SI, Popescu N, Kraemer KH, Pommier Y. Antiproliferative activity of ecteinascidin 743 is dependent upon transcription-coupled nucleotide-excision repair. Nat Med. 2001 Aug;7(8):961-6. doi: 10.1038/91008. Erratum In: Nat Med 2001 Nov;7(11):1255.
PMID: 11479630
citation: Damia G, Silvestri S, Carrassa L, Filiberti L, Faircloth GT, Liberi G, Foiani M, D'Incalci M. Unique pattern of ET-743 activity in different cellular systems with defined deficiencies in DNA-repair pathways. Int J Cancer. 2001 May 15;92(4):583-8. doi: 10.1002/ijc.1221.
PMID: 11304695
citation: Germano G, Frapolli R, Belgiovine C, Anselmo A, Pesce S, Liguori M, Erba E, Uboldi S, Zucchetti M, Pasqualini F, Nebuloni M, van Rooijen N, Mortarini R, Beltrame L, Marchini S, Fuso Nerini I, Sanfilippo R, Casali PG, Pilotti S, Galmarini CM, Anichini A, Mantovani A, D'Incalci M, Allavena P. Role of macrophage targeting in the antitumor activity of trabectedin. Cancer Cell. 2013 Feb 11;23(2):249-62. doi: 10.1016/j.ccr.2013.01.008.
PMID: 23410977
citation: del Campo JM, Sessa C, Krasner CN, Vermorken JB, Colombo N, Kaye S, Gore M, Zintl P, Gomez J, Parekh T, Park YC, McMeekin S. Trabectedin as single agent in relapsed advanced ovarian cancer: results from a retrospective pooled analysis of three phase II trials. Med Oncol. 2013 Mar;30(1):435. doi: 10.1007/s12032-012-0435-1. Epub 2013 Feb 9.
PMID: 23397080
citation: Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
PMID: 10655437
responsible party type: Sponsor
mesh term: Carcinosarcoma
mesh term: Mixed Tumor, Mullerian
mesh term: Trabectedin
sharing ipd: No