Surgery and chemotherapy for recurrent mucinous ovarian cancer
Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
This study is testing if combining surgery with a special type of heated chemotherapy can help women with recurrent mucinous ovarian cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05123807 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of secondary cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in improving progression-free survival and overall survival in women with recurrent primary mucinous ovarian cancer. The study will also assess the associated toxicity, morbidity, and quality of life following the treatment. Additionally, it will investigate the proportion of patients who are initially deemed operable but may have unresectable disease upon surgical exploration, and it will collect biological samples for future research.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with confirmed recurrent primary mucinous ovarian cancer who meet specific health criteria.
Not a fit: Patients with unresectable disease at the time of surgical exploration or those receiving concurrent investigational therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with recurrent mucinous ovarian cancer.
How similar studies have performed: Other studies have shown promising results with similar surgical and chemotherapy approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Aaron Shafer, MD — M.D. Anderson Cancer Center
- Study coordinator: Aaron Shafer, MD
- Email: AShafer@mdanderson.org
- Phone: 832-885-6133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.