Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: capecitabine; Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00042965

CALGB-90008

U10CA031946 (U.S. NIH Grant/Contract)

CDR0000069488 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine in treating patients who have metastatic kidney cancer.

Full description

OBJECTIVES:

• Determine the objective response rate in patients with metastatic renal cell carcinoma treated with gemcitabine and capecitabine.
• Determine the duration of overall and progression-free survival of patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

  • Clinically confirmed metastatic disease (histologic documentation of metastatic disease not required)

• Sarcomatoid renal cell carcinomas allowed

• No pure sarcomas

• No collecting duct (duct of Bellini) tumors, oncocytomas, or transitional cell tumors

• Measurable disease

  • At least 20 mm by conventional techniques OR

  • At least 10 mm by spiral CT scan

  • Nonmeasurable lesions include the following:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions

• Patients with known brain metastases are eligible if they have undergone prior surgical resection and/or cranial irradiation, they currently do not require steroids or anticonvulsants, and there is no progressive disease on CT scan or MRI at least 4 weeks after completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• 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

Renal

• Creatinine clearance at least 30 mL/min

Cardiac

• No clinically significant cardiac disease
• No congestive heart failure
• No symptomatic coronary artery disease
• No cardiac arrhythmias not well controlled with medication
• No myocardial infarction within the past 12 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study
• No prior severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil
• No malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract that would preclude absorption of capecitabine

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior chemotherapy and recovered
• No prior gemcitabine
• No prior fluoropyrimidines (e.g., fluorouracil, floxuridine, capecitabine, or fluorouracil-uracil)
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• At least 4 weeks since prior megestrol
• No concurrent hormones (e.g., megestrol) except steroids for adrenal failure, hormones for nondisease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• Prior radiotherapy to any lesion that may produce disability (e.g., unstable femur) allowed
• No concurrent palliative radiotherapy

Surgery

• See Disease Characteristics
• At least 4 weeks since prior major surgery and recovered

Other

• Any number of prior regimens allowed

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Gemcitabine + capecitabine

Experimental group

Description:

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Treatment:

Drug: capecitabine

Drug: gemcitabine hydrochloride