Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
This study has been completed.
Sponsor:
Sarah Cannon Research Institute
Collaborators:
Novartis
Pharmacia and Upjohn
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193349
First received: September 12, 2005
Last updated: June 24, 2010
Last verified: January 2008
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Purpose
This study will evaluate combination chemotherapy for patients with extensive stage small cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Imatinib Drug: Irinotecan Drug: Carboplatin |
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: | Phase II Evaluation of Gleevec Combined With Camptosar Plus Paraplatin in Patients With Previously Untreated Extensive Stage SCLC |
Resource links provided by NLM:
Drug Information available for:
Carboplatin
Irinotecan
Irinotecan hydrochloride
Imatinib
Imatinib mesylate
U.S. FDA Resources
Further study details as provided by Sarah Cannon Research Institute:
Primary Outcome Measures:
- Overall response rate
- Response duration
Secondary Outcome Measures:
- Time to progression
- Overall toxicity
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2002 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Upon determination of eligibility, all patients will be receive:
- Irinotecan + Carboplatin + Imatinib
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
- Small cell lung cancer with extensive stage disease confirmed by biopsy
- Measurable or evaluable disease
- Ability to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney
- No active brain metastasis.
- No previous chemotherapy or radiation therapy
- Give written informed consent.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
- Limited stage disease (includes IA, IB, IIA, IIB, and IIIA)
- Active brain metastasis
- Age < 18 years old
- History of a prior malignancy within three years
- Women pregnant or lactating.
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Contacts and Locations More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00193349 History of Changes |
| Other Study ID Numbers: | SCRI LUN 59, CSTI571BUS66, CPTAIV-0020-403 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Irinotecan Imatinib |
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 Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013