Combination of ifosfamide, paclitaxel, and cisplatin for the treatment of metastatic and recurrent carcinoma of the uterine cervix: a phase II study of the Hellenic Cooperative Oncology Group.

Objective: Ifosfamide, paclitaxel, and cisplatin have moderate single-agent activity in patients with metastatic or recurrent cancer of the uterine cervix. We administered a combination of these three agents to a large number of patients with metastatic or recurrent cervical cancer to evaluate its activity.

Methods: Sixty patients were treated on an outpatient basis with Ifosfamide (I) 1500 mg/m(2) intravenously over 1 h on Days 1-3, paclitaxel (T) 175 mg/m(2) as a 3-h intravenous infusion on Day 1, and cisplatin (P) 75 mg/m(2) intravenously over 2 h on Day 2 with granulocyte colony-stimulating factor (G-CSF) support. The chemotherapy was repeated every 4 weeks for a maximum of six courses.

Results: Fifty-seven patients received at least two courses of treatment and are evaluable for response. Twenty-six patients (46%) achieved an objective response, including 19% complete and 27% partial responses. The median duration of response was 11.5 months and the median time to progression and survival for all patients were 8.3 and 18.6 months, respectively. Patients with excellent performance status, with disease recurrence outside the radiation field, and with nonsquamous tumors had the highest response rate and best survival. Some degree of neurotoxicity occurred in 44% of patients. Grade 3 or 4 toxicity included granulocytopenia in 26% of patients, anemia in 13%, thrombocytopenia in 7%, and neurotoxicity in 3%.

Conclusion: The ITP regimen is relatively well tolerated and moderately active in patients with metastatic carcinoma of the uterine cervix. Patients more likely to benefit are those with nonsquamous histology, with excellent performance status, and with disease recurrence outside the radiation field.