A phase II study of gemcitabine and capecitabine in metastatic renal cancer: a report of Cancer and Leukemia Group B protocol 90008.

Abstract

BACKGROUND:

The objective of this study was to verify previous reports of activity with gemcitabine plus a fluoropyrimidine in patients with metastatic renal cell cancer in a multiinstitutional setting.

METHODS:

Eligibility included a Zubrod performance status from 0 to 2, no prior gemcitabine or fluoropyrimidine therapy, and normal organ function. Patients received gemcitabine at a dose of 1000 mg/m2 on Days 1, 8, and 15 and capecitabine at a dose of 830 mg/m2 twice daily on Days 1 through 21 on a 28-day cycle with specified dose reductions for baseline renal insufficiency. The primary endpoint was the response rate, which was assessed every 8 weeks. The statistical plan tested the hypothesis that the response rate was 5% versus an alternative of 15%.

RESULTS:

Sixty patients were enrolled, and 4 of those patients never started treatment. Of the 56 evaluable patients, 79% of patients underwent prior nephrectomy, 75% of patients received prior systemic therapy, and 75% of patients had clear cell histology. Risk stratification revealed that 34%, 43%, and 16% of patients were in Risk Groups 1, 2, and 3, respectively. Toxicity (graded according to the National Cancer Institute's Common Toxicity Criteria [version 2.0]) included Grade 3 or 4 neutropenia in 45% of patients, Grade 2 or greater fatigue in 32% of patients, Grade 2 or greater nausea in 29% of patients, Grade 2 or greater hand-foot reaction in 39% of patients, and Grade 2 or greater diarrhea in 22% of patients. Six patients responded (11%; 95% confidence interval, 4-22%), and the overall median survival was 14.5 months.

CONCLUSIONS:

Gemcitabine plus capecitabine had modest activity in patients with metastatic renal cancer, although the degree of activity and its associated toxicity would not support further evaluation in a Phase III trial of unselected patients. More focused investigations to identify patients most likely to benefit or to enhance activity with additional agents would be reasonable.

• Authors: Walter M Stadler, Susan Halabi, Brian Rini, Marc S Ernstoff, Enrique Davila, Joel Picus, Robert Barrier, Eric J Small, Cancer and Leukemia Group B
• Journal: Cancer (Cancer) Vol. 107 Issue 6 Pg. 1273-9 (Sep 15 2006) ISSN: 0008-543X [Print] United States
• PMID: 16909426 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: (c) 2006 American Cancer Society.

Chemical References

• Deoxycytidine
• Capecitabine
• Fluorouracil
• Gemcitabine

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Capecitabine
• Carcinoma, Renal Cell (drug therapy, pathology)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Drug Administration Schedule
• Female
• Fluorouracil (analogs & derivatives)
• Humans
• Kidney Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Metastasis
• Survival Analysis
• Treatment Outcome
• Gemcitabine