A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin
- Conditions
- Recurrent Ovarian Cancer
- Sponsor
- Columbia University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Adverse Event Rate and/or Laboratory Changes
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.
Detailed Description
This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically confirmed ovarian, primary peritoneal or fallopian tube carcinoma.
- •Patients must have measurable evidence of recurrent intraabdominal disease based on Computed tomography (CT scan) findings.
- •Patients must fulfill the following with regard to prior chemotherapy:
- •4 weeks or greater since conclusion of prior chemotherapy;
- •Prior intraperitoneal chemotherapy with cisplatin is acceptable; and,
- •Prior systemic chemotherapy is acceptable.
- •Patients must have a Karnofsky Performance Status of \> 70%
- •Patients must have an estimated life expectancy of at least 16 weeks.
- •Patient assurance of study compliance and geographic proximity that allows for adequate follow-up.
- •Patients must have adequate organ function at the screening visit as defined by the following laboratory values:
Exclusion Criteria
- Not provided
Arms & Interventions
Out-Patient Intraperitoneal Chemotherapy
Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle.
Intervention: Cisplatin
Out-Patient Intraperitoneal Chemotherapy
Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle.
Intervention: Doxorubicin
Outcomes
Primary Outcomes
Adverse Event Rate and/or Laboratory Changes
Time Frame: 5 years
The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.
Toxicity Rating Based on NCI Common Toxicity Criteria
Time Frame: Up to 5 years
Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).
Secondary Outcomes
- Kaplan-Meier Curves for Patient Overall Survival(Up to 5 years, survival)
- Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)(Up to 5 years (survival))