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

NCT02199171 | Completed Phase 1 DMC

• 2 other identifiers: UCI 13-54 HS# 2014-11882014-1188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

FIGO Stage IIC-IV Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Keywords

hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) carboplatin; intraperitoneal (IP) chemotherapy; cytoreductive surgery

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of HIPEC carboplatin

  MTD of HIPEC carboplatin, defined as the dose level with \< 2 patients of 6 experiencing dose-limiting toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Identified using the continual reassessment method.

  Up to 30 days after study treatment

Secondary Outcomes (7)

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

  Up to 1 year

• 1-year overall survival (OS) rate

  At 1 year

• Incidence of adverse events assessed using Common Toxicity Criteria version 4.0

  Up to 30 days after study treatment

• Change in pharmacokinetic profile of HIPEC carboplatin

  Baseline and at 5, 15, 30, 45, and 60 minutes

• Changes in tissue temperature during HIPEC compared to conventional temperature measures (esophageal and bladder)

  Baseline to after completion of HIPEC

Study Arms (1)

HIPEC carboplatin

EXPERIMENTAL

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)

Drug: carboplatin

Interventions

carboplatin DRUG

Given via HIPEC

Also known as: (SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O']platinum, 1,1-cyclobutanedicarboxylic acid platinum complex, 19314, 241240, 41575-94-4, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, cis-diammine(1,1-cyclobutanedicarboxylato) platinum(II), cis-diammine(cyclobutane-1,1-dicarboxylato)platinum, cis-diammine(cyclobutanedicarboxylato)platinum II, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, platinum, diammine(1,1-cyclobutanedicarboxylato(2-))-, (SP-4-2), Platinwas, Ribocarbo

HIPEC carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Carboplatin; Platinum

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Krishnansu Tewari, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 24, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)