Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Lung Cancer
• Interventions: Drug: gemcitabine hydrochloride; Drug: imatinib mesylate

• Registration Number: NCT00323362
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate.

Secondary

* Assess time to progression in patients treated with this regimen.

* Assess overall survival and 1-year survival of patients treated with this regimen.

* Assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study.

Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-03-07
• Study Start: 2006-04
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2013-11-18
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-25
• Last Update Submitted: 2014-04-25
• Results First Posted: 2014-05-22
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine hydrochloride and imatinib mesylate	imatinib mesylate	-
Gemcitabine hydrochloride and imatinib mesylate	gemcitabine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Meet Critieria for Response	2 years	Response is considered Partial Response or Complete Response as per RECIST criteria.; Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Secondary Outcome Measures

Name	Time	Method
Time to Progression	2 years
1-year Survival	3 years	Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.

Trial Locations

Locations (3)

Saint Peter's University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Cancer Institute of New Jersey at Hamilton; 🇺🇸 Hamilton, New Jersey, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States