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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193349
First Posted: September 19, 2005
Last Update Posted: June 28, 2010
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.
Collaborators:
Novartis
Pharmacia and Upjohn
Information provided by:
SCRI Development Innovations, LLC
  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
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

Resource links provided by NLM:


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

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)
Detailed Description:

Upon determination of eligibility, all patients will be receive:

  • Irinotecan + Carboplatin + Imatinib
  Eligibility

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, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00193349


Sponsors and Collaborators
SCRI Development Innovations, LLC
Novartis
Pharmacia and Upjohn
Investigators
Principal Investigator: Anthony Greco, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00193349     History of Changes
Other Study ID Numbers: SCRI LUN 59
CSTI571BUS66
CPTAIV-0020-403
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: June 28, 2010
Last Verified: January 2008

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Irinotecan
Carboplatin
Imatinib Mesylate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors