A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

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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