At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Clinical Observation, Laboratory Biomarker Analysis, and 3 other interventions for Fallopian Tube Clear Cell Adenocarcinoma and 26 related conditions. Targeting 1,157 participants across 315 sites.
Detailed 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.
Study Details
Timeline
Interventions
Undergo observation
Correlative studies
Given IV
Given IV
Ancillary studies