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
Condition: Recurrent Ovarian Cancer; Fallopian Tube Cancer
MeSH terms: Fallopian Tube Neoplasms; Recurrence
Intervention: Cisplatin; Doxorubicin
Intervention description: Cisplatin (75 mg/m2) prepared in 2L normal saline.; Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).
Intervention MeSH terms: Cisplatin; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary peritoneal

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.
    

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).