Clinical trial NCT05123807: Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
Official title: Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 30
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: The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Detailed description: PRIMARY OBJECTIVE:

The primary objective is to estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

SECONDARY OBJECTIVES:

* To estimate overall survival (OS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
* To evaluate toxicity and morbidity of secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
* To estimate quality of life after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
* To estimate what proportion of patients who preoperatively appear to be candidates for secondary cytoreductive surgery and HIPEC are found to have unresectable disease at time of surgical exploration
* To collect blood and tumor samples for biobanking to be used for exploratory endpoints

Eligibility criteria: Inclusion Criteria:

* Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer
* Age ≥18 years
* ECOG performance status ≤ 2
* Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration):

  1. absolute neutrophil count \>1,500/mcL
  2. platelets \>100,000/mcL
  3. total bilirubin ≤ 1.5 mg/dL
  4. creatinine ≤ 1.5 mg/dL
  5. AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
* Patients must be \> 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires \>6 weeks
* Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria:

* Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
* Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin
* Patients with known active CNS metastases
* Patients with known hypersensitivity to any of the components of cisplatin
* Patients with a prior or concurrent malignancy who natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* 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
* Women who are pregnant or nursing women
* Patients with peripheral neuropathy ≥ grade 2
* History of allogenic transplant
* History of prior HIPEC or intraperitoneal chemotherapy
* Known bulky extra-abdominopelvic disease
* Patients with hearing impairment/tinnitus ≥ grade 2

Primary outcomes:
measure: To estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
timeFrame: through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Aaron Shafer, MD
role: PRINCIPAL_INVESTIGATOR
References: