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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Small Cell Lung

Treatments

Drug: carboplatin

Drug: bevacizumab

Drug: irinotecan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00294931

AVF3256s

SCRI LUN 90

Details and patient eligibility

About

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.

Full description

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

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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