Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer

Brief Title

Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer

Official Title

A Phase I Dose-escalation and Pharmacokinetic Study of Hyperthermic Intraoperative Intraperitoneal Chemotherapy (HIPEC) Carboplatin at the Time of Cytoreductive Surgery for the Initial Treatment in Patients With Advanced Ovarian, Fallopian Tube, and Peritoneal Carcinomas.

Brief Summary

      This phase I trial studies the side effects and best dose of heated carboplatin given into
      the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian
      tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it
      directly into the area around the tumor during surgery may kill more tumor cells.

Detailed Description

      Primary Objectives:

      To determine the maximum tolerated dose (MTD) of carboplatin given as HIPEC for primary
      treatment of women with advanced ovarian, peritoneal, and fallopian tube cancers.

      Secondary Objectives:

        1. To determine the dose limiting toxicities of HIPEC carboplatin.

        2. To describe the pharmacokinetic profile of HIPEC carboplatin.

        3. To quantify changes in tissue temperature during HIPEC and compare to conventional
           temperature measures (esophageal and bladder).

        4. To describe the extent of thermal damage and DNA platinum adduct formation in tissues
           resulting from HIPEC carboplatin.

      OUTLINE: This is a dose escalation study.

      Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the
      planned surgical cytoreductive procedure.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum tolerated dose (MTD) of HIPEC carboplatin

Secondary Outcome

 Disease control rates, scored according to Response Evaluation Criteria in Solid Tumors criteria and consist of complete response, partial response, and stable disease

Condition

FIGO Stage IIC-IV Ovarian Carcinoma

Intervention

carboplatin

Study Arms / Comparison Groups

 HIPEC carboplatin

Description:  Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure.
Doses as appropriate for assigned dose level in 500 cubic centimeters (cc)

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

Start Date

July 2014

Completion Date

October 2017

Primary Completion Date

October 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed, known or highly
             suspected advanced (International Federation of Gynecology and Obstetrics [FIGO] stage
             II-IV) ovarian, primary peritoneal, or fallopian tube cancer, scheduled for primary or
             interval cytoreductive surgery

          -  If the patient has received pre-operative neoadjuvant chemotherapy, evidence of
             response must be documented by at least one of the following: decline in serum
             carcinoma antigen (CA)125 level, at least a 30% decrease in the sum of the longest
             diameter of target lesions on radiographic imaging, or resolution of ascites or
             pleural effusion(s)

          -  Women of all races and ethnic groups are eligible for this trial

          -  Gynecologic Oncology Group (GOG) performance status =< 2

          -  Leukocytes >= 3,000/microliter (mcL)

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             (SGOT))/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT))
             =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Albumin >= 2.5 mg/dL

          -  Patients for whom the diagnosis of high-grade serous or undifferentiated carcinoma of
             ovarian, peritoneal, or fallopian tubal origin is confirmed at surgery

          -  Surgery achieves either no gross residual disease or optimal cytoreductive status
             defined as no single lesion measuring more than 1 cm in its greatest diameter (this
             protocol calls for the intentional delay in resection of up to 3 tumors per patient
             until the HIPEC procedure is complete; the surgeon will identify these tumors as
             easily resectable from a technical and safety aspect)

          -  Patients must be stable from cardiopulmonary and hemodynamic standpoints to continue
             with prolonged surgery and anesthesia

          -  Provision of written informed consent

        Exclusion Criteria:

          -  Patients receiving neo-adjuvant chemotherapy whose disease has progressed following at
             least 3 cycles, defined by at least one of the following: clinical deterioration (new
             or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction,
             declining performance status), new lesion(s) or increase in maximal diameter of > 20%
             of the two largest target lesions, rising CA-125 (an increase of at least 10% of
             baseline value that increases over 3 values obtained every 21 days)

          -  Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery

          -  Patients found to have non-gynecologic, uterine, or breast primary at surgery

          -  Patients with gynecologic malignancy of low-grade serous or borderline histology

          -  Patients with sub-optimal resection (any single tumor larger than 1 cm)

          -  Patients with core body temperature > 37 degrees Celsius (C) at completion of
             cytoreductive surgery and prior to HIPEC

          -  Patients who are receiving other investigational therapeutic agents

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Krishnansu Tewari, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02199171

Organization ID

UCI 13-54 HS# 2014-1188

Secondary IDs

2014-1188

Responsible Party

Principal Investigator

Study Sponsor

University of California, Irvine

Study Sponsor

Krishnansu Tewari, MD, Principal Investigator, University of California, Irvine

Verification Date

January 2020