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A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers

Phase 2
18 Years
Open (Enrolling)
Recurrent Ovarian Cancer,, Fallopian Tube Cancer

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Trial Information

A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancers

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.

Inclusion Criteria:

1. Patients must have histologically confirmed ovarian, primary peritoneal or fallopian
tube carcinoma.

2. Patients must have measurable evidence of recurrent intraabdominal disease based on
Computed tomography (CT scan) findings.

3. Patients must fulfill the following with regard to prior chemotherapy:

1. 4 weeks or greater since conclusion of prior chemotherapy;

2. Prior intraperitoneal chemotherapy with cisplatin is acceptable; and,

3. Prior systemic chemotherapy is acceptable.

4. Patients must have a Karnofsky Performance Status of > 70%

5. Patients must have an estimated life expectancy of at least 16 weeks.

6. Patient assurance of study compliance and geographic proximity that allows for
adequate follow-up.

7. 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

[8] Patient must have signed informed consent

[9] Patient must be at least 18 years of age

[10] Following cytoreductive surgery, patient's residual disease should be no larger than
1cm to Receive HIPEC and continue with normothermic IP chemotherapy

-Exclusion criteria

1. Have active peripheral neuropathy of Grade 2 or greater intensity, as defined by the
National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE;
Version 4).

2. Have experienced myocardial infarction within 6 months prior to enrollment or have
New York Hospital Association (NYHA) Class III or IV heart failure (see section
16.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
electrocardiographic evidence of acute ischemia or active conduction system

3. Prior radiation therapy within 4 weeks of enrollment.

4. Have uncontrolled active systemic infection requiring therapy.

5. Have a history of allergic reaction attributable to compounds containing boron or
mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.

6. Have had a serious concomitant systemic disorders (including oncologic emergencies)
incompatible with the study (at the discretion of the investigator).

7. Have had a "currently active" second malignancy other than non-melanoma skin cancer
or carcinoma in situ of the cervix are not to be registered. Patients who are not
considered to have a "currently active" malignancy if they have completed therapy and
are considered by their physician to be at less than 30% risk of relapse.

8. Have had any investigational agent within 4 weeks before enrollment into the study.

9. Have a history of a serious medical or psychiatric illness preventing informed
consent or, in the opinion of the investigator, would make the patient a poor study

10. Evidence of extraabdominal metastasis on preinclusion thoracic computed tomography
(CT) scans (i.e. brain or chest disease).

Type of Study:


Study Design:

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

Outcome Measure:

Adverse Event Rate and/or laboratory changes

Outcome Description:

The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Sharyn Lewin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

December 2016

Related Keywords:

  • Recurrent Ovarian Cancer,
  • Fallopian Tube Cancer
  • Primary peritoneal
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms



Columbia University Medical CenterNew York, New York  10032