Clinical Trial: Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naive Patients With Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (

Brief Summary: This randomized phase III trial studies paclitaxel and carboplatin see how well it works compared with paclitaxel and ifosfamide in treating patients with newly diagnosed persistent or recurrent uterine, ovarian, fallopian tube, or peritoneal cavity cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy.

SECONDARY OBJECTIVES:

I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior progression-free survival when compared to ifosfamide, mesna, and paclitaxel chemotherapy.

II. To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin chemotherapy is reduced compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.

III. To determine if treatment with combination paclitaxel and carboplatin chemotherapy is associated with superior patient-reported quality of life and neurotoxicity scores compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.

TERTIARY OBJECTIVES:

I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and deoxyribonucleic acid (DNA) extracted from whole blood for future research.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes on day 1.

ARM II: Patients receive paclitaxel as in arm I and ifosfamide IV over 1 hour on days 1-3.

In both arms, treatment repeats ev
Sponsor: Gynecologic Oncology Group

Current Primary Outcome: Overall survival [ Time Frame: Up to 6 years ]

Original Primary Outcome: Duration of overall survival

Current Secondary Outcome:

  • Duration of progression-free survival [ Time Frame: Up to 6 years ]
    Assessed using a stratified Cox proportional hazards model.
  • Incidence of adverse events as assessed by CTCAE version 3.0 [ Time Frame: Up to 6 years ]
    The maximum grade over the entire course of therapy for any individual effect will be used as a summary of acute toxicity. The Kruskal-Wallis test corrected for ties will be used to compare the maximum grade of acute adverse effects of therapy by treatment arm.
  • Quality of life measured using the Functional Assessment of Cancer Therapy (FACT)-general, Physical Well-being and Functional Well-being subscales, FACT-endometrial, and FACT/GOG-NTtx subscale [ Time Frame: Up to 30 weeks following initiation of therapy ]


Original Secondary Outcome:

  • Duration of progression-free survival
  • Toxicity as assessed by CTCAE version 3.0
  • Quality of life


Information By: Gynecologic Oncology Group

Dates:
Date Received: August 6, 2009
Date Started: August 2009
Date Completion:
Last Updated: December 23, 2014
Last Verified: December 2014