Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
NCT01970722 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-03-05
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.
Conditions
- FIGO Stage IVA Ovarian Cancer
- FIGO Stage IVB Ovarian Cancer
- Platinum-Resistant Ovarian Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Uterine Corpus Carcinoma
- Stage III Fallopian Tube Cancer AJCC v7
- Stage III Ovarian Cancer AJCC v6 and v7
- Stage III Primary Peritoneal Cancer AJCC v7
- Stage III Uterine Corpus Cancer AJCC v7
- Stage IIIA Fallopian Tube Cancer AJCC v7
- Stage IIIA Ovarian Cancer AJCC v6 and v7
- Stage IIIA Primary Peritoneal Cancer AJCC v7
- Stage IIIA Uterine Corpus Cancer AJCC v7
- Stage IIIB Fallopian Tube Cancer AJCC v7
- Stage IIIB Ovarian Cancer AJCC v6 and v7
- Stage IIIB Primary Peritoneal Cancer AJCC v7
- Stage IIIB Uterine Corpus Cancer AJCC v7
- Stage IIIC Fallopian Tube Cancer AJCC v7
- Stage IIIC Ovarian Cancer AJCC v6 and v7
- Stage IIIC Primary Peritoneal Cancer AJCC v7
- Stage IIIC Uterine Corpus Cancer AJCC v7
- Stage IV Fallopian Tube Cancer AJCC v6 and v7
- Stage IV Ovarian Cancer AJCC v6 and v7
- Stage IV Primary Peritoneal Cancer AJCC v7
- Stage IV Uterine Corpus Cancer AJCC v7
- Stage IVA Uterine Corpus Cancer AJCC v7
- Stage IVB Uterine Corpus Cancer AJCC v7
Interventions
- DRUG
-
Given IP or IV
- DRUG
-
Given IP
- DRUG
-
Gemcitabine Hydrochloride
Given IP or IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Thanh Dellinger · City of Hope Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-19
- Primary Completion
- 2027-01-05
- Completion
- 2027-01-05
Countries
- United States
Study Locations
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