Status:
COMPLETED
Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Small Cell Lung Cancer
Extensive Stage Lung Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
PHASE2
Brief Summary
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases a...
Detailed Description
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 combinat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00856830
Start Date
April 1 2009
End Date
May 1 2016
Last Update
July 17 2017
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294 - 0104
2
Georgia Cancer Specialists
Marietta, Georgia, United States, 30060