Trials / Active Not Recruiting

Active Not RecruitingNCT01970722

Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer

Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 40 (estimated)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up. SECONDARY OBJECTIVES: I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP chemotherapy (no HIPEC) for women with ovarian cancer. II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up. III. To estimate progression-free survival (PFS). IV. To collect biospecimens and perform correlative translational studies focused on understanding the mechanisms of action of HIPEC on ovarian cancer. OUTLINE: Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (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 intravenously (IV) at the discretion of the medical and gynecologic oncologists. After completion of study treatment, patients are followed up at 3-6, 6-9, 9-12, and 12-15 months; every 3 months for 1 year; and then every 4 months for 1 year.

Conditions

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IP or IV
DRUG	Cisplatin	Given IP
DRUG	Gemcitabine Hydrochloride	Given IP or IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IP or IV
DRUG	Pegylated Liposomal Doxorubicin Hydrochloride	Given IP or IV
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

Start date: 2014-05-19
Primary completion: 2027-01-05
Completion: 2027-01-05
First posted: 2013-10-28
Last updated: 2026-03-05

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01970722. Inclusion in this directory is not an endorsement.