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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

Phase 1/Phase 2
18 Years
79 Years
Open (Enrolling)
Small Cell Lung Cancer, Extensive Stage Lung Cancer, Chemonaive

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Trial Information

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

We are proposing a novel combination of bendamustine plus irinotecan followed by the
standard regimen of etoposide with carboplatin. This will allow the investigation of
response to the novel combination as well as any improvement in outcomes compared to
historical controls.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) and safety of the combination bendamustine and irinotecan in chemotherapy-naive patients with extensive SCLC

Outcome Time Frame:

9 weeks - regimen given every 3 weeks for 3 cycles

Safety Issue:


Principal Investigator

Francisco Robert, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

December 2015

Related Keywords:

  • Small Cell Lung Cancer
  • Extensive Stage Lung Cancer
  • Chemonaive
  • Small cell lung cancer
  • Chemonaive
  • Bendamustine
  • Irinotecan
  • Etoposide
  • Carboplatin
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Georgia Cancer SpecialistsDecatur, Georgia  30033
University of Alabama at BirminghamBirmingham, Alabama  35294-3300