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WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01144442
First received: May 26, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Carcinoma
Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin
Other: Isotonic saline (perfusate)
Procedure: Surgery
Drug: Carboplatin
Drug: Paclitaxel

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27) ] [ Designated as safety issue: No ]
    We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.

  • Feasibility of HIPC in Recurrent Disease Setting [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.


Secondary Outcome Measures:
  • Quality of Life Measurements [ Time Frame: Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27 ] [ Designated as safety issue: No ]
    The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.

  • Progression-free Survival [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).

  • Overall Survival [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.


Enrollment: 10
Study Start Date: August 2010
Estimated Study Completion Date: September 2017
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIPC Treatment
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin
Carboplatin at a dose of 1000mg/m^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes.
Other: Isotonic saline (perfusate)
The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.
Other Name: saline
Procedure: Surgery

The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus.

If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach.

Drug: Carboplatin
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
Drug: Paclitaxel
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
Other Name: Taxol

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.
  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144442

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Peter Argenta, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01144442     History of Changes
Other Study ID Numbers: 2009LS114, WCC# 59, 1003M78874
Study First Received: May 26, 2010
Results First Received: June 25, 2013
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
recurrent ovarian cancer
recurrent fallopian tube cancer
recurrent peritoneal carcinoma

Additional relevant MeSH terms:
Carcinoma
Fallopian Tube Neoplasms
Fever
Ovarian Neoplasms
Recurrence
Adnexal Diseases
Body Temperature Changes
Disease Attributes
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Pathologic Processes
Signs and Symptoms
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014