Phase I/IIa Study of the Novel Combination of Bendamustine With Irinotecan Followed by Etoposide/Carboplatin in Chemonaive 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.