Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT03188432 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB00044434NCI-2017-01045CCCWFU 83216P30CA012197
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well hyperthermic intraperitoneal chemotherapy works in improving quality of life in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill any cancer cells left over after surgery.

Conditions

Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O)

  This is a descriptive study. QOL will be measured using the Fact-O questionnaire and treated as a continuous outcome. The distribution of QOL at 6 weeks post-treatment will be examined. Descriptive statistics such as mean, standard deviation, median and interquartile range will be calculated. The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life.

  At 6 weeks post treatment

Secondary Outcomes (7)

• Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire

  Pre-treatment (baseline), 3 months after surgery, 6 months after surgery

• Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)

  Up to 6 weeks post treatment

• Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire

  Up to 6 months

• Progression Free Survival

  Up to 2 years from study enrollment

• Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)

  At 3 months post treatment

Study Arms (1)

Treatment - Carboplatin, CRS, HIPEC

EXPERIMENTAL

Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS.

Drug: Carboplatin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Cytoreductive Surgery

Interventions

Carboplatin DRUG

Given IV and IP

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment - Carboplatin, CRS, HIPEC

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment - Carboplatin, CRS, HIPEC

Questionnaire Administration OTHER

Ancillary studies

Treatment - Carboplatin, CRS, HIPEC

Cytoreductive Surgery PROCEDURE

Undergo CRS

Also known as: Operation, Surgery, Surgical, Surgical Interventions, Surgical Procedure, Surgical Procedures

Treatment - Carboplatin, CRS, HIPEC

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 non-mucinous, epithelial stage 3 or 4 carcinoma of the ovary, fallopian tube or peritoneum.
• Patients must not have received treatment for another malignancy within 3 years of enrollment (patients who have received hormone therapy within 3 years of enrollment are still eligible).
• Patients must have received at least 3 but not more than 6 cycles of carboplatin-doublet based IV neoadjuvant chemotherapy and achieved at least stable disease (radiographically confirmed) at the conclusion of this therapy.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Patients must have adequate organ and marrow function as defined below (within 30 days of registration):
• Absolute neutrophil count \>= 1,500/mcL (within 30 days of registration)
• Platelets \>= 75,000/mcL (within 30 days of registration)
• Total bilirubin =\< 1.5 mg/dL (within 30 days of registration)
• Creatinine clearance \>= 50 mg/dL (within 30 days of registration)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal (within 30 days of registration)
• Alkaline phosphatase =\< 3 x institutional upper limit of normal (within 30 days of registration)
• The effects of HIPEC on the developing human fetus are unknown. For this reason, and because carboplatin doublet therapy consists of pregnancy category D agents, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document.

You may not qualify if:

• Patients may not be receiving any other investigational agents.
• Patients with extra-abdominal metastatic disease.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin doublet 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 because carboplatin doublet therapy consists of pregnancy category D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin doublet therapy, breastfeeding should be discontinued.
• Men are excluded from participating due to the site specific nature of the disease being studied.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Carboplatin; Cytoreduction Surgical Procedures; Surgical Procedures, Operative

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; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Principal investigator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

Michael.G.Kelly@advocatehealth.org

3367135440

Study Officials

• Michael Kelly

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: January 2, 2019
• Primary Completion: January 31, 2024
• Study Completion: February 8, 2024
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Locations

US (1)