Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060359
Status:
COMPLETED
Last Update Posted:
2015-05-08
First Post:
2003-05-06
Brief Title:
Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial Peritoneal or Fallopian Tube Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of CT-2103 and Carboplatin NSC 214240 in Patients With Previously Untreated Epithelial Ovarian Primary Peritoneal or Fallopian Tube Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
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 phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial peritoneal or fallopian tube cancer Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of polyglutamate paclitaxel in combination with carboplatin in patients with chemotherapy-naïve ovarian epithelial primary peritoneal or fallopian tube carcinoma
II Determine the feasibility of this regimen at the MTD in an expanded cohort of patients
III Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort
IV Determine the toxicity profile of this regimen in these patients V Determine the pharmacokinetics and pharmacodynamics of this drug combination in these patients
OUTLINE This is an open-label multicenter dose-escalation study of polyglutamate paclitaxel CT-2103 followed by a feasibility multicenter study
DOSE-ESCALATION PHASE Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CT-2103 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment
FEASIBILITY PHASE Once the MTD of CT-2103 is determined an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
I Determine the maximum tolerated dose MTD of polyglutamate paclitaxel in combination with carboplatin in patients with chemotherapy-naïve ovarian epithelial primary peritoneal or fallopian tube carcinoma
II Determine the feasibility of this regimen at the MTD in an expanded cohort of patients
III Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort
IV Determine the toxicity profile of this regimen in these patients V Determine the pharmacokinetics and pharmacodynamics of this drug combination in these patients
OUTLINE This is an open-label multicenter dose-escalation study of polyglutamate paclitaxel CT-2103 followed by a feasibility multicenter study
DOSE-ESCALATION PHASE Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CT-2103 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment
FEASIBILITY PHASE Once the MTD of CT-2103 is determined an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above
Patients are followed every 3 months for 2 years and then every 6 months for 3 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 |
|---|---|---|---|
| NCI-2012-02532 | REGISTRY | None | None |
| CDR0000301642 | None | None | None |
| GOG-9914 | OTHER | None | None |
| GOG-9914 | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |