Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003385
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Untreated Ovarian Peritoneal or Fallopian Tube Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Study of Paclitaxel Carboplatin and Increasing Doses of Doxil in Untreated Ovarian Peritoneal and Tubal Carcinoma
Status:
COMPLETED
Status Verified Date:
2003-09
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin paclitaxel and carboplatin in treating patients who have untreated ovarian peritoneal or fallopian tube cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin paclitaxel and carboplatin in treating patients who have untreated ovarian peritoneal or fallopian tube cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with paclitaxel and carboplatin in patients with previously untreated ovarian epithelial peritoneal or fallopian tube cancer
Determine the toxicity of this treatment regimen in these patients
Evaluate measurable disease in patients treated with this regimen
OUTLINE This is a dose-escalation study of doxorubicin HCl liposome LipoDox
Patients receive LipoDox IV on day 1 carboplatin IV over 3 hours on days 1 and 22 and paclitaxel IV over 1 hour on days 1 8 15 22 29 and 36 Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of LipoDox 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 An additional cohort of 12 patients receives LipoDox at the MTD with carboplatin and paclitaxel as above
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 48 patients will be accrued for this study within 2 years
Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with paclitaxel and carboplatin in patients with previously untreated ovarian epithelial peritoneal or fallopian tube cancer
Determine the toxicity of this treatment regimen in these patients
Evaluate measurable disease in patients treated with this regimen
OUTLINE This is a dose-escalation study of doxorubicin HCl liposome LipoDox
Patients receive LipoDox IV on day 1 carboplatin IV over 3 hours on days 1 and 22 and paclitaxel IV over 1 hour on days 1 8 15 22 29 and 36 Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of LipoDox 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 An additional cohort of 12 patients receives LipoDox at the MTD with carboplatin and paclitaxel as above
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 48 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-9703 | None | None | None |