A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Small Cell Lung
Trial Information
A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. The
interval between chemotherapy courses will be 28 days. If after 6 courses of treatment,
patient's response is a CR/PR/SD they will continue on Bevacizumab until tumor progression
or up to 6 cycles (6 months) total.
Treatment sequence:
- Irinotecan 60mg/m2 on days 1, 8, and 15
- Carboplatin AUC=4 day 1 only
- Bevacizumab 10 mg/kg days 1 and 15
Inclusion Criteria:
- Histologically confirmed small cell lung cancer,extensive stage disease.
- Measurable or evaluable disease
- No previous chemotherapy
- Able to perform activities of daily living with minimal assistance
- Adequate hematological, live and kidney function
- Provide written informed consent
Exclusion Criteria:
- Limited stage disease
- PEG or G tubes
- Hemoptysis
- Abdominal fistula, perforation, or abscess within the previous 6 months
- Women who are pregnant or lactating
- Proteinuria
- Serious nonhealing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled or serious cardiovascular disease
- Uncontrolled brain metastasis
- Major surgical procedure, open biopsy, or significant traumatic injury within 28
days; Fine needle aspiration within 7 days
- Patients requiring full-dose anticoagulation must be on a stable dosing schedule
prior to enrollment
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
median time to progression
Principal Investigator
David R. Spigel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
SCRI LUN 90
NCT ID:
NCT00294931
Start Date:
February 2006
Completion Date:
January 2009
Related Keywords:
- Carcinoma, Small Cell Lung
- Lung Cancer, Small Cell
- Extensive
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Small Cell
Name | Location |
|---|---|
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| Oncology Hematology Care | Cincinnati, Ohio 45242 |
| Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
