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Completed

NCT Number: NCT00193349

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, all patients will be receive:

  • Irinotecan + Carboplatin + Imatinib

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imatinib

Drug

Irinotecan

Drug

carboplatin

Drug

Primary outcomes

  1. Overall response rate

  2. Response duration

Secondary outcomes

  1. Time to progression

  2. Overall toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Novartis
  • Pharmacia and Upjohn

Registry information

Official study title

Phase II Evaluation of Gleevec Combined With Camptosar Plus Paraplatin in Patients With Previously Untreated Extensive Stage SCLC

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Jun 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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