A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
18 Years
N/A
Both
Kidney Cancer
Trial Information
A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
OBJECTIVES:
- Determine response (confirmed and unconfirmed complete and partial) of patients with
advanced renal cell cancer treated with gemcitabine and capecitabine.
- Determine the 6-month time to treatment failure rate and overall survival rate of
patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Correlate, preliminarily, tumor response with the intratumoral content of the enzymes
involved in the activation and degradation of these drugs in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral
capecitabine twice daily on days 1-21. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 3.8-4.2
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed renal cell carcinoma
- Metastatic (M1) disease OR
- M0 provided the primary tumor is unresectable
- Measurable disease
- At least 1 unidimensionally measurable lesion
- Soft tissue disease that has been irradiated within the past 2 months is not
considered measurable disease
- Soft tissue disease within a prior radiation field is measurable provided it has
progressed since therapy and there is also measurable disease outside of the
irradiated field
- No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (SGOT) no greater than 1.5 times ULN
Renal
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other concurrent uncontrolled illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No uncontrolled diabetes mellitus
- No ongoing or active infection
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer
currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No more than 2 prior immunotherapy regimens comprising interferon (IFN) and/or
interleukin-2 (IL-2)
- At least 28 days since prior IFN or IL-2 and recovered
Chemotherapy
- No prior chemotherapy for renal cell cancer
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to 25% or more of the bone marrow
- At least 21 days since prior radiotherapy and recovered
Surgery
- At least 28 days since prior surgery and recovered
- Prior resection of the primary tumor allowed (in patients with metastatic disease)
Other
- At least 4 weeks since prior sorivudine or brivudine
- No concurrent sorivudine or chemically related analogues (e.g., brivudine)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Outcome Time Frame:
every 8 weeks until progression
Safety Issue:
No
Principal Investigator
Peter J. VanVeldhuizen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kansas City Veteran Affairs Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000288820
NCT ID:
NCT00058318
Start Date:
December 2004
Completion Date:
November 2008
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- stage III renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
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