Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive 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: NCT00294931
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : June 28, 2010
Genentech, Inc.
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Lung Drug: irinotecan Drug: carboplatin Drug: bevacizumab Phase 2

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Study Start Date : February 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. median time to progression

Secondary Outcome Measures :
  1. overall 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.

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,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

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): NCT00294931

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.
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results: Identifier: NCT00294931     History of Changes
Other Study ID Numbers: SCRI LUN 90
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: January 2009

Keywords provided by SCRI Development Innovations, LLC:
Lung Cancer, Small Cell

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action