Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer
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 or 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.
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
Drug: paclitaxel poliglumex
Other: clinical observation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 (IND #70177), 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|
- Overall survival [ Time Frame: From protocol entry to death due to any cause, or for living patients, date of last contact, up to 5 years ] [ Designated as safety issue: No ]
- 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 5 years ] [ Designated as safety issue: No ]
- Frequency and severity of adverse effects assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Quality of life assessed by Functional Assessment of Cancer Therapy-Ovarian-Trial Outcome Index (FACT-O-TOI) and Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity version 4 (FACT-GOG/NTX4) [ Time Frame: Up to 24 months after study enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Estimated Primary Completion Date:||January 2022 (Final data collection date for primary outcome measure)|
Experimental: Arm I (paclitaxel poliglumex)
Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel poliglumex
Active Comparator: Arm II (paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Arm III (observation)
Patients receive no further anticancer treatment until evidence of disease progression.
Other: clinical observation
Other Name: observation
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.
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: This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). 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.
Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 10 years.