Status:
TERMINATED
WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
16-90 years
Phase:
NA
Brief Summary
This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adju...
Detailed Description
OBJECTIVES * The primary objectives are * to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fa...
Eligibility Criteria
Inclusion
- Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according.
- Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual.
- End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm.
- Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease.
- Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma.
- Patients must have platin sensitive disease, defined as a recurrence occurring greater than 6 months from cessation of original treatment.
- Patients must have a performance status of 0, 1, 2.
- Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) ≥1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
- Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
- Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
- Patients who have signed an Institutional Review Board (IRB) approved informed consent.
- Female patients 16-90 years of age.
- Patients must be deemed medically able to undergo a secondary surgical procedure.
- Patient eligibility for systemic chemotherapy following HIPC:
- Patients must have successfully completed HIPC within 6 weeks of first prescribed intravenous carboplatin and taxane cycle.
- Patients must have a performance status of 0, 1, or 2.
- Patients must have adequate bone marrow function as defined as an ANC ≥ 1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
- Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
- Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
- Patients who have signed an IRB approved informed consent.
Exclusion
- Patients with known recurrent disease outside the abdominal cavity.
- Patients with low malignant tumor at primary diagnosis as determined by pathologic review.
- Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy.
- Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer.
- Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis.
- Patients with history of grade 3 or greater gastrointestinal bleeding.
- Patients with a GOG performance score of 3 or 4.
- Patients deemed medically unable to tolerate the HIPC procedure by care giving physician.
- Patients with known allergy to platinum chemotherapy agents.
- Patients with equal to or greater than grade 2 neuropathy.
Key Trial Info
Start Date :
July 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01144442
Start Date
July 27 2010
End Date
May 1 2015
Last Update
July 30 2019
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455