Docetaxel in advanced renal carcinoma. A phase II trial of the National Cancer Institute of Canada Clinical Trials Group.

Abstract

BACKGROUND:

Most patients diagnosed with renal carcinoma developed metastatic disease at some time during their course, with available therapy inducing response in only a small proportion of patients. Docetaxel (Taxotere, RP56976) a semi-synthetic analogue of paclitaxel with a broad range of in vitro antitumor activity, was evaluated in a phase II study.

METHODS:

Eligibility criteria included histologically proven metastatic or advanced, bidimensionally measurable disease, no prior chemotherapy, immunotherapy, or hormonal therapy, adequate hematologic (neutrophils > or = 2.0 x 10(9)/L, platelets > or = 100 x 10(9)/L) and biochemical (serum creatinine and bilirubin < or = 1.5 x normal, transaminases < or = 3 x normal) parameters, WHO performance status of at least 2, and a life expectancy of > 12 weeks. Docetaxel was administered in a dose of 100 mg/m2 as a 1 hour intravenous infusion every 3 weeks. The first 2 patients entered onto the study were not premedicated for hypersensitivity reactions; subsequent patients received dexamethasone 10 mg and diphenhydramine 50 mg i.v. 30 minutes prior to docetaxel.

RESULTS:

Twenty patients were entered onto the study, with 2 considered inevaluable for response. Sixty cycles of therapy were administered, with only 2 cycles delivered at a dose of 55 mg/m2 or less. No objective responses were seen; 1 patient demonstrated a mixed response. Neutropenia was significant, with 42/60 cycles developing grade 3/4 granulocytopenia. Fifty-five percent of patients demonstrated hypersensitivity reactions despite the premedication regimen employed, higher than that of the phase I studies which established the dose and schedule used in this trial.

CONCLUSIONS:

1) Docetaxel is an ineffective agent in advanced renal carcinoma. 2) The high rate of hypersensitivity reactions suggests the need for more intensive premedication and/or slower infusion times at this dose level.

• Authors: W C Mertens, E A Eisenhauer, J Jolivet, S Ernst, M Moore, A Muldal
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 5 Issue 2 Pg. 185-7 (Feb 1994) ISSN: 0923-7534 [Print] England
• PMID: 7910480 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel
• Paclitaxel

Topics

• Adult
• Aged
• Antineoplastic Agents, Phytogenic (therapeutic use)
• Docetaxel
• Drug Hypersensitivity
• Female
• Humans
• Kidney Neoplasms (drug therapy)
• Male
• Middle Aged
• Paclitaxel (adverse effects, analogs & derivatives, therapeutic use)
• Taxoids