This phase II trial studies the effects of giving a dose of heated chemotherapy (gemcitabine) in the abdomen immediately after cytoreductive surgery in patients with uterine leiomyosarcoma that has come back (locally recurrent). Cytoreductive surgery is a surgical procedure that aims to remove all visible tumors from the abdominal cavity. Heated chemotherapy is a treatment that uses heated chemotherapy inside the abdomen at the time of surgery to try to eliminate any remaining cancer cells and decrease chances of disease recurrence. Chemotherapy drugs, such as gemcitabine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving a dose of heated chemotherapy in the abdomen immediately after cytoreductive surgery may lower the risk of the cancer coming back in the future.
Additional locations may be listed on ClinicalTrials.gov for NCT04727242.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Kristen Nooshin Ganjoo
Phone: 650-725-6413
PRIMARY OBJECTIVE:
I. To assess the efficacy of cytoreductive surgery with gemcitabine hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative systemic chemotherapy with dacarbazine in subjects with locally recurrent uterine leiomyosarcoma (LMS).
SECONDARY OBJECTIVES:
I. To assess the safety of cytoreductive surgery with gemcitabine HIPEC in subjects with locally recurrent uterine LMS.
II. To assess the 6 month and 12 month intraabdominal relapse free survival in subjects with locally recurrent uterine LMS.
III. To determine quality of life prior to therapy (within 28 days prior to surgery with gemcitabine hyperthermic intraperitoneal chemotherapy [HIPEC]) and 4 to 6 weeks after surgery with HIPEC.
EXPLORATORY OBJECTIVES:
I. To collect biospecimens and perform correlative studies to examine circulating tumor deoxyribonucleic acid (DNA) levels before surgery and at every odd cycle of systemic chemotherapy (cycles 1, 3, 5).
II. To collect biospecimens and perform NextGen sequencing of tumors to look at mutations.
OUTLINE:
Patients undergo cytoreductive surgery and receive HIPEC with gemcitabine intraperitoneally (IP) over 60 minutes on day 0. Beginning 30 days after surgery, patients receive dacarbazine intravenously (IV) every 3 weeks (Q3W) for up to 6 doses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for years 1 and 2, every 4 months for year 3, and then every 6 months for years 4 and 5.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorKristen Nooshin Ganjoo
