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WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence


N/A
16 Years
90 Years
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma

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Trial Information

WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Response

Outcome Description:

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.

Outcome Time Frame:

After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)

Safety Issue:

No

Principal Investigator

Peter Argenta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2009LS114

NCT ID:

NCT01144442

Start Date:

August 2010

Completion Date:

September 2017

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Carcinoma
  • recurrent ovarian cancer
  • recurrent fallopian tube cancer
  • recurrent peritoneal carcinoma
  • Carcinoma
  • Fever
  • Ovarian Neoplasms
  • Recurrence
  • Fallopian Tube Neoplasms

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455