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

Rutgers The State University of New Jersey

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: imatinib mesylate

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00323362

0220060014 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

NJ1505 (Other Identifier)

CDR0000539557

030503 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell cancer
- Recurrent disease after adjuvant treatment OR progressive disease after 1 prior treatment for recurrent or metastatic disease
Received at least 1 prior chemotherapy regimen and meets the following criteria:
- No more than 1 prior chemotherapeutic regimen in the recurrent or metastatic setting
- Patients who received prior chemotherapy in the adjuvant setting are eligible when 1 of the following criteria is met:
  - 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