Trials / Completed
CompletedNCT02199171
Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer
A Phase I Dose-escalation and Pharmacokinetic Study of Hyperthermic Intraoperative Intraperitoneal Chemotherapy (HIPEC) Carboplatin at the Time of Cytoreductive Surgery for the Initial Treatment in Patients With Advanced Ovarian, Fallopian Tube, and Peritoneal Carcinomas.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects and best dose of heated carboplatin given into the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it directly into the area around the tumor during surgery may kill more tumor cells.
Detailed description
Primary Objectives: To determine the maximum tolerated dose (MTD) of carboplatin given as HIPEC for primary treatment of women with advanced ovarian, peritoneal, and fallopian tube cancers. Secondary Objectives: 1. To determine the dose limiting toxicities of HIPEC carboplatin. 2. To describe the pharmacokinetic profile of HIPEC carboplatin. 3. To quantify changes in tissue temperature during HIPEC and compare to conventional temperature measures (esophageal and bladder). 4. To describe the extent of thermal damage and DNA platinum adduct formation in tissues resulting from HIPEC carboplatin. OUTLINE: This is a dose escalation study. Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin | Given via HIPEC |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2017-10-01
- Completion
- 2017-10-01
- First posted
- 2014-07-24
- Last updated
- 2020-01-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02199171. Inclusion in this directory is not an endorsement.