Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
Malignant Ovarian Mixed Epithelial Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Primary Peritoneal Carcinoma
Stage III Ovarian Cancer
Undifferentiated Ovarian Carcinoma
Procedure: Peripheral Blood Stem Cell Transplantation
Drug: Topotecan Hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcinoma|
- Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
- Indication of excessive toxicity defined as hospitalization > 14 days per course, delay of day 1 therapy > 14 days, or grade 3 (irreversible) or grade 4 vital organ toxicity (non-hematologic) [ Time Frame: Up to 11 years ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
- PFS [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 1999|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Combination chemotherapy, PBSC)
See detailed description.
Other Names:Drug: Cyclophosphamide
Other Names:Biological: Filgrastim
Other Names:Drug: Paclitaxel
Other Names:Procedure: Peripheral Blood Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplantation
Other Names:Drug: Topotecan Hydrochloride
I. Determine the safety and feasibility of multiple courses of high dose carboplatin, paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma.
II. Determine the pathological complete response rate, disease free survival, and overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells.
High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients receive paclitaxel IV over 24 hours beginning on day 1, immediately followed by carboplatin IV over 2 hours, immediately followed by topotecan IV over 24 hours. Patients receive G-CSF sub-cutaneously (SQ) daily beginning 24 hours after completion of topotecan infusion and continuing until blood counts have recovered for 2 days. One quarter of the PBSC are reinfused beginning 2 days after completion of topotecan infusion. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo laparoscopy as second look surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is found during laparoscopy, then exploratory laparotomy must also be performed.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004221
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Russell Schilder||Gynecologic Oncology Group|