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

NCT ID: NCT00323362

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-10-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine hydrochloride and imatinib mesylate

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.

imatinib mesylate

Intervention Type: DRUG

400 mg/day orally, given Days 1-5 and 8-12 every 21 days

Interventions

gemcitabine hydrochloride

1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.

Intervention Type: DRUG

imatinib mesylate

400 mg/day orally, given Days 1-5 and 8-12 every 21 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• In first recurrence (after 1 prior regimen)
• Received first-line chemotherapy in the recurrent setting after 2 prior regimens
• Measurable disease

• Must have ≥ 1 measurable target lesion outside prior radiotherapy field OR radiologic confirmation of disease progression within a prior radiotherapy field
• No known or untreated brain metastases or carcinomatous meningitis

• Clinically stable, treated brain metastases allowed provided it has been > 7 days since prior steroids

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy ≥ 3 months
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Able to swallow oral medication
• No concurrent medical condition that would preclude study compliance
• No history of allergic reaction to compounds of similar chemical or biological composition to gemcitabine hydrochloride or imatinib mesylate
• No uncontrolled illness that would preclude study compliance, including any of the following:

• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia requiring therapy
• Myocardial infarction within the past 6 months
• Active infection
• No New York Heart Association class III-IV congestive heart failure
• No chronic liver disease (i.e., chronic active hepatitis, cirrhosis)
• No HIV positivity
• No other primary malignancies within the past 5 years, except carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• At least 3 weeks since prior anti-vascular endothelial growth factor therapy and recovered
• At least 3 weeks since prior radiotherapy and recovered
• More than 28 days since prior and no other concurrent investigational or commercial agents
• More than 2 weeks since prior major surgery
• No prior gemcitabine hydrochloride or imatinib mesylate for metastatic disease
• No prior tyrosine kinase inhibitor, except for gefitinib or erlotinib hydrochloride
• No concurrent therapeutic warfarin (prophylactic warfarin therapy ≤ 1 mg daily allowed)
• No other concurrent medications that would preclude study compliance
• No concurrent chronic systemic corticosteroids

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mika Sovak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

030503

Identifier Type: OTHER

Identifier Source: secondary_id

0220060014

Identifier Type: OTHER

Identifier Source: secondary_id

NJ1505

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000539557

Identifier Type: -

Identifier Source: org_study_id