Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer

• Sponsor: SCRI Development Innovations, LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT00193349
• Collaborator: Novartis (Industry), Pharmacia and Upjohn (Industry)
• Enrollment: 60
• Duration (Months): 63

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Imatinib; Drug: Irinotecan; Drug: Carboplatin	Phase 2

Detailed Description

Upon determination of eligibility, all patients will be receive:

• Irinotecan + Carboplatin + Imatinib

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Overall response rate []

2. Response duration []

Secondary Outcome Measures

1. Time to progression []

2. Overall toxicity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• SCRI Development Innovations, LLC
• Novartis
• Pharmacia and Upjohn

Investigators

• Principal Investigator: Anthony Greco, MD, SCRI Development Innovations, LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Published article in the Journal of Thoracic Oncology

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00193349
• Other Study ID Numbers: SCRI LUN 59; CSTI571BUS66; CPTAIV-0020-403
• First Posted: Sep 19, 2005
• Last Update Posted: Jun 28, 2010
• Last Verified: Jan 1, 2008

• Additional relevant MeSH terms: Lung Neoplasms; Carboplatin; Irinotecan; Imatinib Mesylate

Study Results

No Results Posted as of Jun 28, 2010