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

NCT ID: NCT01659554

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

Brief Summary

The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.

Detailed Description

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.

Conditions

Recurrent Ovarian Cancer; Fallopian Tube Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Out-Patient Intraperitoneal Chemotherapy

Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle.

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Cisplatin (75 mg/m2) prepared in 2L normal saline.

Doxorubicin

Intervention Type: DRUG

Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).

Interventions

Cisplatin

Cisplatin (75 mg/m2) prepared in 2L normal saline.

Intervention Type: DRUG

Doxorubicin

Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).

Intervention Type: DRUG

Other Intervention Names

cis-diamminedichloroplatinum(II) (CDDP); Platinol; Platinol-AQ; hydroxyldaunorubicin; Adriamycin

Eligibility Criteria

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 ULN

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 abnormalities.

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 candidate.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharyn Lewin, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAI1246

Identifier Type: -

Identifier Source: org_study_id