Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369954
Status:
WITHDRAWN
Last Update Posted:
2013-06-10
First Post:
2006-08-29
Brief Title:
Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer Primary Peritoneal Cancer or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Trial of Intravenous Gemcitabine NSC 613327 and Intraperitoneal Carboplatin NSC 241240 in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian Primary Peritoneal or Fallopian Tube Carcinoma With Non-Measurable Disease
Status:
WITHDRAWN
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was never activated
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 such as gemcitabine and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy and giving them in different ways may kill more tumor cells
PURPOSE This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer that responded to previous cisplatin or carboplatin
PURPOSE This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer that responded to previous cisplatin or carboplatin
Detailed Description:
OBJECTIVES
Primary
Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial fallopian tube or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin
Evaluate the systemic and regional toxicity of this regimen in these patients
Secondary
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
Primary
Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial fallopian tube or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin
Evaluate the systemic and regional toxicity of this regimen in these patients
Secondary
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
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-0102H | None | None | None |