Phase II clinical trial of docetaxel in refractory squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study.

Abstract

OBJECTIVE:

A phase II study was conducted to evaluate the antitumor activity and adverse effects of docetaxel in patients with previously treated squamous cell carcinoma of the cervix.

METHODS:

Eligible patients were to have measurable disease and not more than one prior chemotherapy regimen. Docetaxel 100 mg/m was administered intravenously over 1 hour. This treatment was repeated every 21 days until progression of disease or adverse effects prohibited further therapy.

RESULTS:

Twenty-seven patients were entered onto this study, of whom 23 were eligible and evaluable. There were 2 (8.7%) partial responses. Eight patients (34.8%) had stable disease and 9 patients (39.1%) had increasing disease. The median time to progression was 3.8 months (range, 1.2-11.7 months), while median survival time was 7.0 months (range, 1.8-23.0 months). The most frequently reported adverse events were neutropenia, infection, gastrointestinal, and constitutional.

CONCLUSIONS:

Docetaxel has minimal activity in refractory squamous cell carcinoma of the cervix at the dose and schedule tested.

• Authors: Agustin A Garcia, John A Blessing, Luis Vaccarello, Lynda D Roman, Gynecologic Oncology Group Study
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 30 Issue 4 Pg. 428-31 (Aug 2007) ISSN: 1537-453X [Electronic] United States
• PMID: 17762444 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)

Chemical References

• Antineoplastic Agents
• Taxoids
• Docetaxel

Topics

• Adult
• Antineoplastic Agents (therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, pathology)
• Docetaxel
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Salvage Therapy
• Survival Rate
• Taxoids (therapeutic use)
• Uterine Cervical Neoplasms (drug therapy, pathology)