Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108745
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2005-04-18
Brief Title:
Paclitaxel Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial Peritoneal Cancer or Fallopian Tube Cancer
Sponsor:
GOG Foundation
Organization:
GOG Foundation
Study Overview
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 Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary PlatinumTaxane Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 platinumtaxane-based chemotherapy consolidationmaintenance 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
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 platinumtaxane-based chemotherapy consolidationmaintenance 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00586 | REGISTRY | None | None |
| 07-117 | None | None | None |
| CDR0000422427 | None | None | None |
| GOG-0212 | OTHER | None | None |
| GOG-0212 | None | None | None |
| GOG-0212 | OTHER | None | None |
| U10CA180868 | NIH | None | None |