Multi-center phase II trial of weekly paclitaxel plus cisplatin combination chemotherapy in patients with advanced gastric and gastro-esophageal cancer.

OBJECTIVE This study is performed to evaluate the response rate, time to progression and safety of the combination chemotherapy with weekly paclitaxel plus cisplatin in advanced gastric and gastro-esophageal cancer. METHODS The paclitaxel 100 mg/m(2) was administered through a 1 h intravenous infusion on Days 1 and 8. The cisplatin 30 mg/m(2) was also administered along with a program of forced diuresis that included at least 2000 ml of fluids after the paclitaxel infusion over 30 min on Days 1 and 8. The chemotherapy was given every 21 days and continued until disease progression, patient refusal or an unacceptable toxicity up to nine cycles. RESULTS Forty-seven (95.9%) of the 49 patients were assessable for response. Two cases of complete response and 19 cases of partial response were confirmed, giving an overall response rate of 42.9% (95% CI, 29.0-56.8%). The median time to progression and overall survival for all patients were 5.9 months (95% CI, 1.6-9.1 months) and 11.2 months (95% CI, 6.1-21.3 months). The most severe hematologic adverse event was neutropenia, which occurred with a Grade 3 intensity in 17.0% and Grade 4 in 4.3%. Grade 3 vomiting, peripheral neuropathy and elevated transaminase were observed in 4.3%, 4.3% and 2.1% of patients. CONCLUSIONS Combination of weekly paclitaxel plus cisplatin is an active regimen with excellent tolerability as a first-line treatment of advanced gastric and gastro-esophageal cancer.