Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003944
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin Paclitaxel and Topotecan With Peripheral Blood Stem Cell PBSC Support as Initial Chemotherapy in Patients With Suboptimally Debulked Stage III or IV Ovarian Fallopian Tube or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have stage III or stage IV ovarian fallopian tube or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have stage III or stage IV ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine pathological complete response rate in patients with suboptimally debulked stage III or stage IV ovarian fallopian tube or primary peritoneal carcinoma treated with sequential paclitaxel carboplatin and topotecan with peripheral blood stem cell rescue II Determine disease free and overall survival of these patients
OUTLINE Patients receive mobilization with cyclophosphamide IV over 1 hour followed 4 hours later by paclitaxel IV over 24 hours Filgrastim G-CSF is administered subcutaneously beginning 24 hours after completion of paclitaxel and continues through stem cell harvest Peripheral blood stem cells PBSC are harvested and selected for CD34 cells High dose sequential chemotherapy begins 21 days after leukapheresis Patients receive paclitaxel IV over 24 hours on day 1 carboplatin IV over 2 hours on day 2 and then topotecan IV over 24 hours G-CSF is administered subcutaneously beginning on day 3 until blood counts recover PBSC are reinfused on day 4 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with radiographic and biochemical complete response undergo second look surgery within 8 weeks of completing the last course of chemotherapy
PROJECTED ACCRUAL Approximately 28 patients will be accrued for this study
OUTLINE Patients receive mobilization with cyclophosphamide IV over 1 hour followed 4 hours later by paclitaxel IV over 24 hours Filgrastim G-CSF is administered subcutaneously beginning 24 hours after completion of paclitaxel and continues through stem cell harvest Peripheral blood stem cells PBSC are harvested and selected for CD34 cells High dose sequential chemotherapy begins 21 days after leukapheresis Patients receive paclitaxel IV over 24 hours on day 1 carboplatin IV over 2 hours on day 2 and then topotecan IV over 24 hours G-CSF is administered subcutaneously beginning on day 3 until blood counts recover PBSC are reinfused on day 4 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with radiographic and biochemical complete response undergo second look surgery within 8 weeks of completing the last course of chemotherapy
PROJECTED ACCRUAL Approximately 28 patients will be accrued for this study
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-G99-1536 | OTHER | National Cancer Institute | None |
| FCCC-98030 | OTHER | None | None |