Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
This study has been completed.
Sponsor:
Sarah Cannon Research Institute
Collaborator:
Genentech
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00294931
First received: February 20, 2006
Last updated: June 24, 2010
Last verified: January 2009
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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 Sarah Cannon Research Institute:
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) |
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
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
Sarah Cannon Research Institute
Genentech
Investigators
| Principal Investigator: | David R. Spigel, MD | Sarah Cannon Research Institute |
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 Sarah Cannon Research Institute:
|
Lung Cancer, Small Cell Extensive |
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 May 16, 2013