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
30
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