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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193349
• Other study ID #: SCRI LUN 59
• Secondary ID: CSTI571BUS66CPTA
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 24, 2010
• Start date: September 2002
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Upon determination of eligibility, all patients will be receive:

• Irinotecan + Carboplatin + Imatinib

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• Imatinib

• Irinotecan

• Carboplatin

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Novartis, Pharmacia and Upjohn

References & Publications (1)

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 I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Primary	Response duration
Secondary	Time to progression
Secondary	Overall toxicity

External Links

•   Published article in the Journal of Thoracic Oncology