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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:
Collaborators:
Novartis
Pharmacia and Upjohn
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193349
First received: September 12, 2005
Last updated: June 24, 2010
Last verified: January 2008
  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:


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

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
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: 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
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
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014