Brief Title
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
Official Title
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Adverse Event Rate and/or Laboratory Changes
Secondary Outcome
Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)
Condition
Recurrent Ovarian Cancer
Intervention
Cisplatin
Study Arms / Comparison Groups
Out-Patient Intraperitoneal Chemotherapy
Description: Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle.
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
4
Start Date
March 2012
Completion Date
April 2014
Primary Completion Date
April 2014
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).
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sharyn Lewin, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01659554
Organization ID
AAAI1246
Responsible Party
Sponsor
Study Sponsor
Columbia University
Study Sponsor
Sharyn Lewin, MD, Principal Investigator, Columbia University
Verification Date
January 2017