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

Completed · Phase 1

Conditions studied: FIGO Stage IIC-IV Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma

In brief

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.

Key facts

Study ID: NCT02199171
Run by: University of California, Irvine
People needed: 30
Starts: 2014-07-01
Expected to finish: 2017-10-01
Last updated by the study team: 2020-01-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Chao Family Comprehensive Cancer Center — Orange, California, United States

Full record on ClinicalTrials.gov

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