Ovarian Cancer
Conditions
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
Interventions
OTHERCytoreductive surgery
(an operation to remove as much tumor tissue as possible) with hyperthermic intraperitoneal chemotherapy
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer | through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion |
Countries
United States
Contacts
CONTACTAaron Shafer, MD
PRINCIPAL_INVESTIGATORAaron Shafer, MD
M.D. Anderson Cancer Center
Outcome results
None listed