Trials / Unknown

UnknownNCT00108745

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

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, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

Status: Unknown
Phase: Phase 3
Study type: Interventional
Enrollment: 1,157 (actual)

Sponsor: GOG Foundation · Network
Sex: Female
Age: —
Healthy volunteers: Not accepted

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 description

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 treatment arms. ARM I: Patients receive polyglutamate paclitaxel intravenously (IV) over 10-20 minutes on day 1. ARM II: Patients receive paclitaxel IV over 3 hours on day 1. ARM III: Patients receive no further anticancer treatment until evidence of disease progression. In arms I and II, treatment repeats every 28 days for up to 12 courses 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 10 years.

Conditions

Interventions

Type	Name	Description
OTHER	Clinical Observation	Undergo observation
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IV
DRUG	Paclitaxel Poliglumex	Given IV
PROCEDURE	Quality-of-Life Assessment	Ancillary studies

Timeline

Start date: 2005-03-21
Primary completion: 2015-02-03
Completion: 2022-02-22
First posted: 2005-04-19
Last updated: 2021-09-30
Results posted: 2021-04-01

Locations

315 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00108745. Inclusion in this directory is not an endorsement.