Brief Title
WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
Official Title
WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence
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 adjuvant chemotherapy. It is expected that this first surgery was
optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence
of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate)
heated and administered into the abdomen, followed by hyperthermic intraperitoneal
chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after
surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6
cycles.
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, fallopian
tube, or primary peritoneal carcinoma
- to determine the feasibility of delivering HIPC in a recurrent setting.
- Secondary objectives are
- to determine disease free survival (DFS) and overall survival (OS),
- to determine treatment related changes in quality of life (QOL)
- to monitor the toxicities and complications associated with HIPC.
Study Type
Interventional
Primary Outcome
Clinical Response
Secondary Outcome
Quality of Life Measurements
Condition
Ovarian Cancer
Intervention
Hyperthermic intraperitoneal chemotherapy with Carboplatin
Study Arms / Comparison Groups
HIPC Treatment
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
10
Start Date
July 27, 2010
Completion Date
May 1, 2015
Primary Completion Date
September 25, 2013
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender
Female
Ages
16 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Peter Argenta, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01144442
Organization ID
2009LS114
Secondary IDs
WCC# 59
Responsible Party
Sponsor
Study Sponsor
Masonic Cancer Center, University of Minnesota
Study Sponsor
Peter Argenta, MD, Principal Investigator, Masonic Cancer Center, University of Minnesota
Verification Date
July 2019