Status:
TERMINATED
Gemcitabine With or Without Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney 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 * Compare stable disease and objective response in patients with metastatic or unresectable renal cell carcinoma treated with gemcitabine hydrochloride with or without imatinib m...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed renal cell carcinoma
- Metastatic disease OR unresectable primary tumor
- No known curative therapy exists
- Documented progressive renal cell carcinoma as defined by RECIST criteria within the past 6 months
- Measurable disease with ≥ 1 unidimensionally measurable lesion
- No known symptomatic brain metastasis or untreated brain metastases or carcinomatous meningitis
- Treated brain metastasis allowed provided the following criteria are met:
- Clinically stable
- More than 7 days since prior steroids
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- 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 nonhormonal contraception during and for 3 months after completion of study treatment
- Must be able to swallow oral medication
- No coexisting medical condition that would preclude study compliance
- No history of allergic reaction to compounds of similar chemical or biological composition to gemcitabine hydrochloride and/or imatinib mesylate
- No uncontrolled illness that would preclude study participation
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia requiring therapy
- No myocardial infarction within the past 6 months
- No active infection
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- No New York Heart Association class III-IV congestive heart failure
- No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
- No known HIV positivity
- No significant history of noncompliance to medical regimens
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No more than 3 prior treatment regimens, including any of the following:
- No more than 1 prior cytotoxic therapy
- Immunotherapy regimens comprising interferon and/or aldesleukin
- Therapy with molecular targets
- Any combination of the above treatments to a maximum of 3 total therapies
- No prior gemcitabine hydrochloride for metastatic disease
- No prior imatinib mesylate for metastatic disease
- More than 2 weeks since prior major surgery
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- At least 3 weeks since prior anti-vascular endothelial growth factor therapy
- At least 3 weeks since prior radiotherapy
- Must have evidence of ≥ 1 measurable target lesion outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy
- At least 28 days since prior and no other concurrent investigational or commercial agents, unless disease is rapidly progressing
- No concurrent therapeutic warfarin
- Concurrent low molecular weight heparin or heparin allowed for therapeutic anticoagulation
- Concurrent prophylactic warfarin therapy ≤ 1 mg daily to maintain catheter patency allowed
- No concurrent filgrastim (G-CSF) for prevention of neutropenia
- No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
- No concurrent routine use (i.e., daily or every other day) of systemic corticosteroid therapy (in supraphysiologic doses)
- No concurrent medication that would preclude study compliance
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00323791
Start Date
April 1 2006
End Date
August 1 2007
Last Update
December 11 2009
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903