Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer

Sponsor

SCRI Development Innovations, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT00308529

Collaborator

Genentech, Inc. (Industry)

Enrollment

Locations

34.1

Duration (Months)

13.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This proposed phase II trial will investigate the combination of irinotecan, carboplatin and bevacizumab along with radiation in the treatment of patients with limited-stage SCLC. This study differs from our "maintenance" bevacizumab trial in that bevacizumab will begin with the initial chemotherapy treatment. Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. Adding a novel minimally toxic agent to this regimen up front may further enhance this doublet's efficacy without contributing to toxicity. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy and chemotherapy in the up front treatment of a common solid tumor.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Small Cell Lung Lung Cancer	Drug: irinotecan Drug: carboplatin Drug: bevacizumab Procedure: Radiation Therapy	Phase 2

Detailed Description

Eligible patients will receive 4 courses of irinotecan, carboplatin, and bevacizumab. Radiation therapy will begin concurrently with the third course of systemic treatment. The intervals between chemotherapy courses will be 28 days.Patients will be completely restaged approximately 2 weeks after completion of chemotherapy prior to beginning treatment with maintenance bevacizumab. Those with progressive tumor or serious toxicity will come off study. Those with stable disease or objective tumor responses will continue treatment with restaging every 12 weeks for a minimum of 6 cycles (6 months).

Induction chemotherapy regimen Irinotecan: 60mg/m2 IV on days 1, 8, and 15 Carboplatin: AUC=4 day 1 only Bevacizumab 10 mg/kg IV days 1, 15 Cycles are repeated every 28 days for four courses
Radiation therapy 1.8 Gy, single daily fractions, concurrently with the third course of chemotherapy e to a total dose of 61.2 Gy (34 fractions). Patients obtaining complete remission or near complete remission will also receive prophylactic whole brain radiotherapy, given within one month after all therapy is completed (total dose 24Gy in 2Gy daily fractions).
Maintenance Bevacizumab Bevacizumab alone at a dose of 10 mg/kg IV days 1 and 15 each cycle, for a maximum of 6 additional cycles (6 months) with restaging every 12 weeks.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Patients With Limited Stage Small Cell Lung Cancer

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

progression-free survival []

Secondary Outcome Measures

toxicity []
overall response rate []
duration of response []
overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically-confirmed small cell lung cancer.
Limited stage disease (
ECOG performance status 0 or 1.
No previous treatment with chemotherapy, radiation therapy, or biologic agents.
Measurable disease
Adequate bone marrow, liver, kidney function
Patients must be able to understand the nature of this study and give written consent.

Exclusion Criteria:

Age < 18 years
History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma, or early stage prostate cancer.
Women who are pregnant or lactating are ineligible. Men and women of childbearing potential are required to use adequate contraception during this study.
History or physical exam evidence of CNS disease (eg seizures not controlled with standard medical therapy, history of stroke)
Active infection requiring parenteral antibiotics
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or fine needle aspiration within 7 days of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study.
Full-dose oral or parenteral anticoagulation must be on a stable dosing schedule prior to enrollment.
Proteinuria
Serious nonhealing wound, ulcer, or bone fracture
Evidence of bleeding diathesis or coagulopathy
Prior hemoptysis.
History of acute myocardial infarction or stroke within 6 months
Uncontrolled hypertension (> 150/100), unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease.
Received other investigational drugs within 28 days
PEG, G-tubes, or other percutaneous drains/tubes
History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or place the subject at high risk for treatment complications
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the previous 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Cancer Specialists	Fort Myers	Florida	United States	33901
2	Oncology Hematology Care	Cincinnati	Ohio	United States	45242
3	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee	United States	37404
4	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37023