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Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00042965
Enrollment
60
Registered
2003-01-27
Start date
2002-10-31
Completion date
2006-09-30
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer, stage IV renal cell cancer

Brief summary

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.

Detailed 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.

Interventions

DRUGcapecitabine
DRUGgemcitabine hydrochloride

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Response rateUp to 2 years

Secondary

MeasureTime frame
Overall survivalUp to 2 years
Progression-free survivalUp to 2 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026