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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.
Full 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.
Enrollment
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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:
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:
Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥8 g/dL Albumin ≥ 2 g/dL Total Bilirubin ≤ 2.5 x ULN* Alkaline phosphatase ≤ 3.0 x ULN* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN Creatinine ≤ 1.5 x ULN
Patient must have signed informed consent
Patient must be at least 18 years of age
Following cytoreductive surgery, patient's residual disease should be no larger than 1cm to Receive HIPEC and continue with normothermic IP chemotherapy
Exclusion criteria
Primary purpose
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4 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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