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

NCT ID: NCT00193349

Last Updated: 2010-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Upon determination of eligibility, all patients will be receive:

* Irinotecan + Carboplatin + Imatinib

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Imatinib

Intervention Type DRUG

Irinotecan

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Pharmacia and Upjohn

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Principal Investigators

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Anthony Greco, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

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Spigel DR, Hainsworth JD, Simons L, Meng C, Burris HA 3rd, Yardley DA, Grapski R, Schreeder M, Mallidi PV, Greco FA; Minnie Pearl Cancer Research Network. Irinotecan, carboplatin, and imatinib in untreated extensive-stage small-cell lung cancer: a phase II trial of the Minnie Pearl Cancer Research Network. J Thorac Oncol. 2007 Sep;2(9):854-61. doi: 10.1097/JTO.0b013e31814617b7.

Reference Type RESULT
PMID: 17805064 (View on PubMed)

Related Links

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Other Identifiers

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CSTI571BUS66

Identifier Type: -

Identifier Source: secondary_id

CPTAIV-0020-403

Identifier Type: -

Identifier Source: secondary_id

SCRI LUN 59

Identifier Type: -

Identifier Source: org_study_id

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