Clinical Trial: Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian,

Brief Summary: This randomized phase III trial studies paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine whether CT-2103 (polyglutamate paclitaxel) or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy ("consolidation/maintenance therapy") will reduce the death rate, compared to re-treatment at the time of documented disease progression.

II. To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the Gynecologic Oncology Group [GOG] NTX4) and superior quality-of-life (as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O]), compared to paclitaxel.

SECONDARY OBJECTIVES:

I. To explore the relationship between expression of several of the angiogenic markers and overall survival or progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.

II. To assess the association among the various tissue and serum markers of angiogenesis, and compare the ability of different combinations of these markers to predict patient outcome including overall survival and progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.

III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.

OUTLINE: Patients are randomized to 1 of 3 treatme
Sponsor: Gynecologic Oncology Group

Current Primary Outcome: Overall survival [ Time Frame: From protocol entry to death due to any cause, or for living patients, date of last contact, up to 12 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Frequency and severity of adverse effects assessed by CTCAE v3.0 [ Time Frame: Up to 30 days post-treatment ]
    Safety endpoints will be summarized with descriptive statistics for the patients in the safety analysis dataset.
  • Progression-free survival [ Time Frame: From protocol entry to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 12 years ]
  • Quality of life assessed by Functional Assessment of Cancer Therapy-Ovarian-Trial Outcome Index and Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity version 4 [ Time Frame: Up to 24 months after study enrollment ]


Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: April 18, 2005
Date Started: March 2005
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017