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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Carcinoma, Small Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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irinotecan

Intervention Type DRUG

carboplatin

Intervention Type DRUG

bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No