Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer

Inclusion Criteria:

• Histologic or cytologic diagnosis of extensive stage SCLC.
• Measurable or assessable tumor parameters.
• ECOG Performance Status 0-2.
• Age between 18 and 79 years (in the State of Alabama > 18).
• Adequate bone marrow, liver and renal function, defined as:
• Absolute neutrophil count (ANC) ≥ 1500/µL
• Hemoglobin ≥ 8g/dl
• Platelet count ≥ 100,000/µL
• SGOT/SGPT ≤ 2 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present.
• Total bilirubin value ≤ 2 x upper limit of normal.
• Serum creatinine value ≤ 2 x upper limit of normal.
• Fully recovered from any previous surgery (at least 4 weeks since major surgery)
• Must have recovered from prior radiation therapy (at least 3 weeks)
• All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
• Must provide written informed consent and authorization to use and disclose health information (HIPAA).
• Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion.
• No prior chemotherapy.

Exclusion Criteria:

• Concurrent cancer chemotherapy, biologic therapy or radiotherapy.
• Administration of any investigational drug within 28 days prior to administration of the current therapy.
• Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery.
• Concurrent serious infection.
• Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study.
• History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years.
• Neuropathy at baseline ≥ Grade 2.
• Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial.
• History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normal frequency) in the past 2 weeks.
• History of a positive serology for human immunodeficiency virus (HIV).
• Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions.
• Pregnant or lactating women.