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

Summary

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.

Conditions

• Fallopian Tube Clear Cell Adenocarcinoma
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube High Grade Serous Adenocarcinoma
• 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
• 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

Interventions

DRUG

Carboplatin

Given IV

DRUG

Paclitaxel

Given IV

DRUG

Ruxolitinib Phosphate

Given PO

PROCEDURE

Therapeutic Conventional Surgery

Undergo TRS

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Charles N Landen · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-14

Primary Completion

2021-09-30

Completion

2024-05-22

Countries

• United States

Study Locations