Phase II trial of irofulven (6-hydroxymethylacylfulvene) for patients with advanced renal cell carcinoma

The aim of this study was to determine the antitumor activity of irofulven (6-hydroxymethylacylfulvene) in patients with advanced renal cell carcinoma (RCC). Eligible patients had advanced renal cell carcinoma with bidimensionally measurable disease, a Karnofsky performance status of at least 70, li...

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Bibliographic Details
Published in:Investigational new drugs 2001-01, Vol.19 (4), p.317-320
Main Authors: BERG, William J, SCHWARTZ, Lawrence, YU, Richard, MAZUMDAR, Madhu, MOTZER, Robert J
Format: Article
Language:English
Subjects:
Adult
Aged
Anemia
Antineoplastic agents
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Apoptosis
Biological and medical sciences
Blood tests
Carcinoma, Renal Cell - drug therapy
Cell cycle
Chemotherapy
Creatinine
Dyspnea
Female
Humans
Infusions, Intravenous
Kidney cancer
Kidney Neoplasms - drug therapy
Life expectancy
Male
Medical sciences
Metastasis
Middle Aged
Neutropenia
Patients
Pharmacology. Drug treatments
Sesquiterpenes - adverse effects
Sesquiterpenes - therapeutic use
Thrombocytopenia
Toxicity
Treatment Outcome
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Summary:The aim of this study was to determine the antitumor activity of irofulven (6-hydroxymethylacylfulvene) in patients with advanced renal cell carcinoma (RCC). Eligible patients had advanced renal cell carcinoma with bidimensionally measurable disease, a Karnofsky performance status of at least 70, life expectancy of greater than three months, no prior treatment with chemotherapy, and no evidence of brain metastases. Irofulven was administered at a dose of 11 mg/m2 by 5-min intravenous infusion, on 5 consecutive days. Cycles were repeated every 28 days. Thirteen patients were enrolled in this study and 12 were evaluable for response. Of the twelve evaluable patients, no major responses were achieved. Eight patients had stable disease as best response. Toxicity included myelosuppression and gastrointestinal side effects. At the dose and schedule used in this trial, irofulven did not produce clinical response in RCC.
ISSN:0167-6997
1573-0646
DOI:10.1023/A:1010609810517