A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal… (NCT01659554) | Clinical Trial Compass
TerminatedPhase 2
A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers
Stopped: Principal Investigator left institution
United States4 participantsStarted 2012-03
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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.
Exclusion criteria
✕. Have active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 4).
What they're measuring
1
Adverse Event Rate and/or Laboratory Changes
Timeframe: 5 years
2
Toxicity Rating Based on NCI Common Toxicity Criteria
✕. Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure (see section 16.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
✕. Prior radiation therapy within 4 weeks of enrollment.
✕. Have uncontrolled active systemic infection requiring therapy.
✕. Have a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
✕. Have had a serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
✕. Have had a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
✕. Have had any investigational agent within 4 weeks before enrollment into the study.