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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

• Nature and Degree of Toxicity [ Time Frame: During study treatment and up to 30 days after stopping study treatment ]
  Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
• Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response [ Time Frame: Response was measured every other cycle (q 6 weeks) until disease progression is documented. ]

  Primary outcome measured according to RECIST v1.0 Best Response:

  Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

  Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: June 2, 2005
Date Started: May 2005
Date Completion:
Last Updated: April 11, 2014
Last Verified: April 2014