Clinical trial NCT03188432: Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-06-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-Ovarian questionnaire
timeFrame: At 6 weeks post treatment
Secondary outcomes:
measure: Abdominal discomfort assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort questionnaire
timeFrame: Up to 6 months
measure: Incidence of toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
timeFrame: Up to 3 months
measure: Neurotoxicity assessed using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire
timeFrame: Up to 6 months
measure: Progression free survival
timeFrame: Up to 1 year
measure: Quality of life (QOL) assessed using Functional Assessment of Cancer Therapy-Ovarian
timeFrame: At 3 months post treatment
measure: Quality of life (QOL) in patients with advanced ovarian cancer assessed using Functional Assessment of Cancer Therapy-Ovarian
timeFrame: At 6 months post treatment
measure: Response rates evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
timeFrame: Up to 1 year post treatment
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Kelly
role: PRINCIPAL_INVESTIGATOR
References: