Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Description

The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Conditions

Ovarian Cancer

Study Overview

Study Details

Study overview

The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Aaron Shafer, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2027-02-02