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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308529
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : June 22, 2010
Genentech, Inc.
Information provided by:
SCRI Development Innovations, LLC

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 55 participants
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 : March 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : January 2009

Primary Outcome Measures :
  1. progression-free survival

Secondary Outcome Measures :
  1. toxicity
  2. overall response rate
  3. duration of response
  4. overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308529

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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
SCRI Development Innovations, LLC
Genentech, Inc.
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Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00308529    
Other Study ID Numbers: SCRI LUN 110
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: January 2009
Keywords provided by SCRI Development Innovations, LLC:
Carcinoma Small Cell Lung
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action