Overview

Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
Summary
This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborator:
Genentech, Inc.
Treatments:
Bevacizumab
Camptothecin
Carboplatin
Irinotecan
Criteria
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