Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Conditions

• FIGO Stage III Ovarian Cancer 2014
• FIGO Stage IIIA Ovarian Cancer 2014
• FIGO Stage IIIA1 Ovarian Cancer
• FIGO Stage IIIA2 Ovarian Cancer
• FIGO Stage IIIB Ovarian Cancer 2014
• FIGO Stage IIIC Ovarian Cancer 2014
• FIGO Stage IVA Ovarian Cancer 2014
• FIGO Stage IVB Ovarian Cancer 2014
• Fallopian Tube Clear Cell Adenocarcinoma
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube High Grade Serous Adenocarcinoma
• Ovarian Clear Cell Adenocarcinoma
• Ovarian Endometrioid Adenocarcinoma
• Ovarian High Grade Serous Adenocarcinoma
• Primary Peritoneal Endometrioid Adenocarcinoma
• Primary Peritoneal High Grade Serous Adenocarcinoma
• Stage III Fallopian Tube Cancer AJCC v7
• Stage III Primary Peritoneal Cancer AJCC v7
• Stage IIIA Fallopian Tube Cancer AJCC v7
• Stage IIIA Primary Peritoneal Cancer AJCC v7
• Stage IIIB Fallopian Tube Cancer AJCC v7
• Stage IIIB Primary Peritoneal Cancer AJCC v7
• Stage IIIC Fallopian Tube Cancer AJCC v7
• Stage IIIC Primary Peritoneal Cancer AJCC v7
• Stage IV Fallopian Tube Cancer AJCC v6 and v7
• Stage IV Primary Peritoneal Cancer AJCC v7

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV
• Ruxolitinib Phosphate — DRUG
  Given PO
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo TRS

Study Details

This phase I/II trial studies the side effects and the best dose of ruxolitinib phosphate when given together with paclitaxel and carboplatin and to see how well they work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 ruxolitinib phosphate together with paclitaxel and carboplatin may be a better treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel and carboplatin alone.

Key Dates

Start date

Nov 14, 2016

Status verified

May 2025

Primary completion

Sep 30, 2021

Completion

May 22, 2024

Study Design

Enrollment

147 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (paclitaxel and carboplatin)
  See Detailed Description.
• Experimental: Arm II (ruxolitinib, paclitaxel, and carboplatin)
  See Detailed Description.

Primary Outcome Measure

Dose-limiting Toxicities (Phase I) [ Time Frame: 42 days (2 cycles) ]

Locations (110)

Find similar trials in Goodyear, AZ

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