- Planned radiotherapy during or after the study chemotherapy prior to disease progression. Chemotherapy or radiation within 28 days of study treatment. Major surgical procedure or a significant traumatic injury within 28 days prior to study treatment. Active infection that would preclude receipt of chemotherapy. Moderate or severe cardiovascular disease. Active pregnancy or lactation. 7. Second primary malignancy for which treatment during the study period would be recommended. 8. Prior malignancy requiring treatment within the last 3 years. Use of another investigational product or device within 4 weeks of study entry or during study participation.