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

Sponsor:	Sarah Cannon Research Institute
Collaborator:	Genentech
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00308529

Purpose

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	Intervention	Phase
Carcinoma, Small Cell Lung Lung Cancer	Drug: irinotecan Drug: carboplatin Drug: bevacizumab Procedure: Radiation Therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Irinotecan U 101440E Irinotecan hydrochloride Bevacizumab

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

progression-free survival

Secondary Outcome Measures:

toxicity
overall response rate
duration of response
overall survival

Estimated Enrollment:	55
Study Start Date:	March 2006
Study Completion Date:	January 2009
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308529

Locations

United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023

Sponsors and Collaborators

Sarah Cannon Research Institute

Genentech

Investigators

Principal Investigator:

David R. Spigel, MD

Sarah Cannon Research Institute

More Information

Additional Information:

Published article in the Journal of Clinical Oncology This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2009 Nov 9.

ClinicalTrials.gov Identifier:	NCT00308529 History of Changes
Other Study ID Numbers:	SCRI LUN 110, AVF3526s
Study First Received:	March 27, 2006
Last Updated:	June 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sarah Cannon Research Institute:

Carcinoma Small Cell Lung
Lung Cancer

Additional relevant MeSH terms:

Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan

Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012