Status:
COMPLETED
Heated Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Peritoneal Cancer
Lead Sponsor:
University of California, Irvine
Conditions:
FIGO Stage IIC-IV Ovarian Carcinoma
Fallopian Tube Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 peritone...
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. Secondar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02199171
Start Date
July 1 2014
End Date
October 1 2017
Last Update
January 31 2020
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868