Surgery + Chemotherapy for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byThanh Dellinger

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and how well surgery and heated chemotherapy with or without non-heated chemotherapy after surgery works in treating patients with ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.

Eligibility Criteria

This trial is for patients with stage III or IV ovarian, fallopian tube, uterine, or peritoneal cancer that's confined to the abdominal cavity. It includes those who've had neoadjuvant chemotherapy and surgery. Participants must be in good physical condition (ECOG <=1 or KPS >=70%), respond well to platinum-based treatments, have no active infections requiring antibiotics, and not be pregnant. They should also have adequate organ function and blood counts.

Inclusion Criteria

Provided informed consent

You have advanced or recurrent ovarian, fallopian tube, peritoneal, or uterine cancer that has spread within the abdomen.

You may need to have a major surgery to remove cancer, and your doctor thinks it's a good idea.

+3 more

Exclusion Criteria

You have cancer in areas outside of the abdomen, such as in the chest with fluid buildup around the lungs. If you had this before but it's no longer there after treatment, you may still be able to join the study.

Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy

Your surgery did not remove all of the unhealthy tissue.

+6 more

Participant Groups

The study tests how effective heated chemotherapy during surgery is compared to adding non-heated chemo after surgery for certain cancers. The goal is to see if heated chemo can better prevent cancer from returning by killing more tumor cells when applied directly into the abdomen during surgical removal of the cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment (surgery, HIPEC cisplatin)Experimental Treatment8 Interventions

Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: