Status:
TERMINATED
Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Novartis
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 m...
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 * Asses...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00323362
Start Date
April 1 2006
End Date
October 1 2008
Last Update
May 22 2014
Active Locations (3)
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1
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
2
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
3
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903