NCT00112489

Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer

A Phase II Evaluation of Paclitaxel (Taxol, NSC # 673089) and Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.

Detailed description

OBJECTIVES: * Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma. * Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	paclitaxel

Timeline

• Start date: 2005-05-01
• Primary completion: 2010-07-01
• First posted: 2005-06-03
• Last updated: 2018-09-25
• Results posted: 2014-05-12

Locations

110 sites across 2 countries: United States, Japan