Randomized phase II trial of either fluorouracil, parenteral hydroxyurea, interferon-α-2a, and filgrastim or doxorubicin/docetaxel in patients with advanced gastric cancer with quality-of-life assessment: Eastern Cooperative Oncology Group study E6296

PURPOSE: The Eastern Cooperative Oncology Group conducted a randomized phase II trial to determine the objective response rates, toxicities, and overall survival and to assess effects on quality of life for two combination regimens in patients with advanced gastric cancer. PATIENTS AND METHODS: All patients had biopsy-proven, untreated metastatic gastric cancer with measurable disease. The FHIG arm employed infusional fluorouracil (F), 2.6 g/m², given intravenously over 24 hours once per week for 6 weeks; infusional hydroxyurea (H), 4.3 g/m², given intravenously over 24 hours once per week for 6 weeks; and interferon-α-2a (I), 9 MU given subcutaneously three times per week, once per week for 6 weeks. The AD arm employed doxorubicin (A), 50 mg/m², and docetaxel (D), 75 mg/m², both given intravenously every 21 days. Quality of life was measured by the FACT-Fatigue scale and a novel questionnaire assessing interferon-mediated fatigue. RESULTS: Twenty-nine patients were enrolled; 23 were eligible and evaluable. Twelve were enrolled on FHIG and 11 on AD. The major grade ≥ 3 toxicities were neuromotor (46%) in patients receiving FHIG and granulocytopenia (91%) in those receiving AD. There were two fatalities in the AD arm. There was one partial responder on FHIG (8.3%) and none on AD. The median survival was 6.6 months for FHIG and 10.1 months for AD. Quality-of-life analysis did not show substantial cumulative fatigue in patients treated with FHIG. CONCLUSIONS: Neither regimen demonstrated enough activity to serve as a platform for the development of further clinical regimens against gastric carcinoma. A subset of patients receiving interferon was able to tolerate therapy without deterioration in quality of life.