NCT02124421 - HOT: HIPEC in Ovarian Cancer as Initial Treatment | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

August 31, 2027

Study Completion Date

April 30, 2028

Conditions

Stage III Ovarian CancerStage IV Ovarian CancerEpithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CarcinomaOvarian CarcinomaFallopian Tube Carcinoma

Interventions

PROCEDURE

Cytoreductive Surgery (CRS)

Cytoreductive surgery

DRUG

Adjuvant Chemotherapy

Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles

OTHER

Questionnaire

Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants

PROCEDURE

Hyperthermic intraperitoneal chemotherapy

Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6

DRUG

Carboplatin

AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.

DRUG

Paclitaxel

175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles

DRUG

Paclitaxel

Day 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles

DRUG

Cisplatin

Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles

Trial Locations (1)

21202

Mercy Medical Center, Baltimore