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

Stage IV Ovarian Cancer Clinical Trial

Official title:

A Phase II Trial Comparing Quality of Life After HIPEC in Patients With Stage IIIC and IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188432
• Other study ID #: IRB00044434
• Secondary ID: NCI-2017-01045CC
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2017
• Est. completion date: February 8, 2024

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. To compare quality of life in patients with advanced ovarian cancer treated with standard of care (SOC) neoadjuvant chemotherapy (NAC) followed by cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) at 6 weeks post-treatment versus quality of life (QOL) patients treatment with intravenous-therapy (IV) chemotherapy.

SECONDARY OBJECTIVES:

I. To describe quality of life in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC at 3 and 6 months post-treatment.

II. To describe neurotoxicity in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

III. To describe abdominal discomfort in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

IV. To describe toxicities in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

V. To describe the response rate in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

VI. To describe progression-free survival (PFS) in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

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

After completion of chemotherapy, patients are followed up at 30 days, and 3, 6, and 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 8, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms
• 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

Intervention

Drug:
• Carboplatin
Given IV and IP

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Cytoreductive Surgery
Undergo CRS

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-Ovarian questionnaire	The longitudinal data of QOL will be displayed graphically with individual trajectories. Repeated measures analysis of covariance models will be used for the primary analysis. The baseline QOL visit (as a categorical variable), randomization assignment, and a randomization by visit interaction will be included in the model. The test for the randomization effect at the 6-week post-treatment will be performed using a contrast of the 6-week randomization means. An unstructured covariance matrix will be used.	At 6 weeks post treatment
Secondary	Abdominal discomfort assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort questionnaire	Abdominal discomfort will be compared between the two treatment arms. The data will be analyzed using Poisson model with GEEs to account for the dependency between repeated measures. This approach will be treated as a sensitivity analysis.	Up to 6 months
Secondary	Incidence of toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	The toxicities will be measured by the number and severity of adverse events defined by CTCAE version 5.0. The count data will be compared assuming a Poisson distribution.	Up to 3 months
Secondary	Neurotoxicity assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire	Neurotoxicity will be compared between the two treatment arms. The data will be analyzed using Poisson model with generalized estimating equations (GEEs) to account for the dependency between repeated measures. This approach will be treated as a sensitivity analysis.	Up to 6 months
Secondary	Progression free survival	Progression free survival will be compared between the two treatment arms using survival analysis. The follow-up time will be calculated from the date of end of treatment. Survival will be measured up to the time until progression, date of last contact, or death, whichever comes first. Kaplan-Meier survival curves will be used to estimate the survival probabilities by treatment arms. Cox proportional hazards models will be used to calculate the hazards ratio and its confidence interval for the treatment effect.	Up to 1 year
Secondary	Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-Ovarian	The test for the randomization effect will be performed using contrasts.	At 3 months post treatment
Secondary	Quality of life (QOL) in patients with advanced ovarian cancer assessed using Functional Assessment of Cancer Therapy-Ovarian	The test for the randomization effect will be performed using contrasts.	At 6 months post treatment
Secondary	Response rates evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	The best response using RECIST criteria will be compared between the two treatment arms over time using GEEs to account for the dependency between repeated measures. Logit link and binomial distribution will be applied. The randomization assignment, visit (as a categorical variable), and interaction between randomization and visit will be included in the model. Contrasts will be used to compare the best response at each time point.	Up to 1 year post treatment