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Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00294931
First received: February 20, 2006
Last updated: June 24, 2010
Last verified: January 2009
  Purpose

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 Intervention Phase
Carcinoma, Small Cell Lung
Drug: irinotecan
Drug: carboplatin
Drug: bevacizumab
Phase 2

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: A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • median time to progression

Secondary Outcome Measures:
  • overall toxicity
  • overall response rate
  • duration of response
  • overall survival

Estimated Enrollment: 50
Study Start Date: February 2006
Study Completion Date: January 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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
  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,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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294931

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
SCRI Development Innovations, LLC
Genentech, Inc.
Investigators
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00294931     History of Changes
Other Study ID Numbers: SCRI LUN 90, AVF3256s
Study First Received: February 20, 2006
Last Updated: June 24, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014