Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003136
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer or Primary Peritoneal Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase III Dose Escalation Trial of Carboplatin With Amifostine Pretreatment to Augment High Dose Cyclophosphamide With Autologous Peripheral Blood Stem Cell Support for the Treatment of Patients With Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of amifostine carboplatin and cyclophosphamide followed by peripheral stem cell transplantation in treating patients with epithelial ovarian cancer or primary peritoneal cancer
PURPOSE Phase III trial to study the effectiveness of amifostine carboplatin and cyclophosphamide followed by peripheral stem cell transplantation in treating patients with epithelial ovarian cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of high dose carboplatin with a fixed dose of high dose cyclophosphamide with amifostine pretreatment and peripheral blood stem cell rescue in patients with ovarian epithelial cancer II Monitor engraftment kinetics such as granulocyte and platelet recovery III Determine the toxic effects of this regimen in this patient population IV Document the response of this patient population to this regimen in terms of time to progression event free survival and overall survival
OUTLINE This is a dose escalation study Patients undergo apheresis over 2-4 days to mobilize peripheral blood stem cells PBSC They then receive amifostine IV over 15 minutes Fifteen minutes later carboplatin is administered over 30 minutes on days -6 through -3 Cyclophosphamide IV is administered 1 hour after the carboplatin infusion is completed on days -6 through -4 PBSC are infused on day 0 Filgrastim G-CSF is administered beginning on day 4 Cohorts of 3-6 patients are treated at each dose level At least 15 days must pass between the day of PBSC infusion and the next dose escalation The dose limiting toxicity DLT is defined as the dose producing grade 3 or 4 nonhematologic toxicity in 2 of 6 patients The maximum tolerated dose MTD is defined as one dose level below the DLT dose At least 6 patients are treated at the MTD Patients are followed monthly for 6 months every 2-3 months for 1 year and annually until death
PROJECTED ACCRUAL This study will accrue 28 patients over 2 years
OUTLINE This is a dose escalation study Patients undergo apheresis over 2-4 days to mobilize peripheral blood stem cells PBSC They then receive amifostine IV over 15 minutes Fifteen minutes later carboplatin is administered over 30 minutes on days -6 through -3 Cyclophosphamide IV is administered 1 hour after the carboplatin infusion is completed on days -6 through -4 PBSC are infused on day 0 Filgrastim G-CSF is administered beginning on day 4 Cohorts of 3-6 patients are treated at each dose level At least 15 days must pass between the day of PBSC infusion and the next dose escalation The dose limiting toxicity DLT is defined as the dose producing grade 3 or 4 nonhematologic toxicity in 2 of 6 patients The maximum tolerated dose MTD is defined as one dose level below the DLT dose At least 6 patients are treated at the MTD Patients are followed monthly for 6 months every 2-3 months for 1 year and annually until death
PROJECTED ACCRUAL This study will accrue 28 patients over 2 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-V97-1357 | None | None | None |
| UCCRC-8433 | None | None | None |
| ALZA-97-005-ii | None | None | None |