Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002474
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer
Sponsor:
Loyola University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of High Dose Cyclophosphamide Mitoxantrone and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
Status:
COMPLETED
Status Verified Date:
2003-03
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 such as cyclophosphamide carboplatin and mitoxantrone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving chemotherapy with autologous bone marrow transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor cells
PURPOSE This phase II trial is studying how well chemotherapy and autologous bone marrow transplant work in treating patients with refractory or recurrent ovarian cancer
PURPOSE This phase II trial is studying how well chemotherapy and autologous bone marrow transplant work in treating patients with refractory or recurrent ovarian cancer
Detailed Description:
OBJECTIVES
Determine the response rate duration of response and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide carboplatin and mitoxantrone followed by autologous bone marrow transplantation
Determine the nonhematopoietic toxicity of this regimen in these patients
OUTLINE Autologous bone marrow is harvested before study entry Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8 -6 and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion
Patients are followed for survival
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 15-3 years
Determine the response rate duration of response and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide carboplatin and mitoxantrone followed by autologous bone marrow transplantation
Determine the nonhematopoietic toxicity of this regimen in these patients
OUTLINE Autologous bone marrow is harvested before study entry Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8 -6 and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion
Patients are followed for survival
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 15-3 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 |
|---|---|---|---|
| CDR0000076845 | REGISTRY | None | None |
| NCI-V91-0058 | Registry Identifier | PDQ Physician Data Query | None |