Gemcitabine and docetaxel for hepatocellular carcinoma: A phase II north central cancer treatment group clinical trial

Steven Robert Alberts, Joel M Reid, Bruce W. Morlan, Gist H. Farr, John K Camoriano, David B. Johnson, James R. Enger, Thomas E. Seay, George P. Kim

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

OBJECTIVES: Few effective options are available for the treatment of unresectable hepatocellular carcinoma (HCC). Several phase I trials suggest promising activity of a combination of gemcitabine and docetaxel. METHODS: Patients with unresectable or metastatic HCC were treated with docetaxel 40 mg/m (later reduced to 30 mg/m) and gemcitabine 800 mg/m on days 1 and 8 every 3 weeks. Twenty-five patients were enrolled in 26 months. Median age was 64 (range, 27-078), 17 were male, 14 had liver-only disease, and 11 had extrahepatic disease. RESULTS: Of 25 patients evaluable for the primary end point (response), 2 (8%) have a confirmed partial response. The median time to progression is 2.76 months (95% confidence interval, 1.84-6.64 mo). Median survival was 12.8 months (95% confidence interval, 5.26-28.00). Two patients died on study owing to adverse events (1 hepatic and 1 renal failure), neither of which were attributed to the study medications. Twenty patients (81%) have experienced grade 3+ adverse events, including 11 with grade 4+ adverse events, primarily neutropenia, thrombocytopenia, diarrhea, and fatigue. CONCLUSIONS: Although this combination seems to have potential benefit, as measured by overall survival, its toxicity and the recent introduction of sorafenib has further limited the use of chemotherapy. Approaches other than chemotherapy are likely to be of the greatest potential benefit.

Original languageEnglish (US)
Pages (from-to)418-423
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume35
Issue number5
DOIs
StatePublished - Oct 2012

Fingerprint

docetaxel
gemcitabine
Hepatocellular Carcinoma
Clinical Trials
Neoplasms
Confidence Intervals
Therapeutics
Drug Therapy
Survival
Neutropenia
Thrombocytopenia
Renal Insufficiency
Fatigue
Liver Diseases
Diarrhea
Liver

Keywords

  • docetaxel
  • gemcitabine
  • hepatocellular carcinoma
  • phase II

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Gemcitabine and docetaxel for hepatocellular carcinoma : A phase II north central cancer treatment group clinical trial. / Alberts, Steven Robert; Reid, Joel M; Morlan, Bruce W.; Farr, Gist H.; Camoriano, John K; Johnson, David B.; Enger, James R.; Seay, Thomas E.; Kim, George P.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 35, No. 5, 10.2012, p. 418-423.

Research output: Contribution to journalArticle

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AU - Enger, James R.

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