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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308529
• Other study ID #: SCRI LUN 110
• Secondary ID: AVF3526s
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2006
• Last updated: June 18, 2010
• Start date: March 2006
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2009
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Carcinoma, Small Cell Lung
• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• irinotecan

• carboplatin

• bevacizumab

Procedure:
• Radiation Therapy

Locations

Country	Name	City	State
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival
Secondary	toxicity
Secondary	overall response rate
Secondary	duration of response
Secondary	overall survival

External Links

•   Published article in the Journal of Clinical Oncology