Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003413
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
High Dose Chemotherapy With Stem Cell Rescue in Recently Diagnosed Patients With Advanced Stage III and IV Ovarian Cancer With 1 cm Residual Disease After Debulking Surgery
Status:
COMPLETED
Status Verified Date:
2019-10
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 with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian epithelial cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Evaluate the complete response rates event free survival and overall survival of patients with recently diagnosed stage III or IV ovarian epithelial cancer receiving carmustine plus melphalan followed by consolidation therapy after having undergone surgical debulking II Evaluate the therapy related mortality associated with the autotransplant and the consolidation therapy in these patients III Evaluate the quality of life in this patient population
OUTLINE Patients are stratified by stage III vs IV and volume of residual disease less than 3 cm vs at least 3 cm Approximately 10-15 days after surgery patients receive filgrastim G-CSF subcutaneously daily until all peripheral blood stem cell PBSC collections have been completed Patients then receive carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1 Peripheral blood stem cells are infused 24 hours after melphalan on day 0 Patients receive G-CSF subcutaneously beginning on day 6 and continuing until granulocytes have recovered Three months after the PBSC infusion patients receive consolidation therapy with paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3 Consolidation treatment is repeated every 3 months for a total of 4 courses Quality of life questionnaires are completed prior to PBSC transplant before discharge after transplant before each consolidation treatment and 3 months after the last consolidation course Patients are followed at least every 3 months for the first 2 years and then every 6 months thereafter
PROJECTED ACCRUAL An estimated 32 patients will be accrued into this study over 3-4 years
OUTLINE Patients are stratified by stage III vs IV and volume of residual disease less than 3 cm vs at least 3 cm Approximately 10-15 days after surgery patients receive filgrastim G-CSF subcutaneously daily until all peripheral blood stem cell PBSC collections have been completed Patients then receive carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1 Peripheral blood stem cells are infused 24 hours after melphalan on day 0 Patients receive G-CSF subcutaneously beginning on day 6 and continuing until granulocytes have recovered Three months after the PBSC infusion patients receive consolidation therapy with paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3 Consolidation treatment is repeated every 3 months for a total of 4 courses Quality of life questionnaires are completed prior to PBSC transplant before discharge after transplant before each consolidation treatment and 3 months after the last consolidation course Patients are followed at least every 3 months for the first 2 years and then every 6 months thereafter
PROJECTED ACCRUAL An estimated 32 patients will be accrued into this study over 3-4 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-V98-1452 | None | None | None |
| MSGCC-9749 | None | None | None |