Ruxolitinib + Chemotherapy for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Led By Robert A Burger

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must have measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

Radiographic imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study entry to time of progression or death, whichever occurs first, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying side effects and the best dose of ruxolitinib when given with paclitaxel and carboplatin to treat patients with ovarian, fallopian tube, or primary peritoneal cancer.

Who is the study for?

This trial is for patients with advanced stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants must have measurable disease, good performance status (able to carry out daily activities), and adequate blood counts. They should not have received prior treatment for their cancer and must be planning to undergo chemotherapy followed by surgery.

What is being tested?

The study is testing the effectiveness of adding ruxolitinib phosphate to the standard chemotherapy drugs paclitaxel and carboplatin in treating these cancers. It's a phase I/II trial aiming to determine the best dose of ruxolitinib phosphate and how well it works with these chemotherapies.

What are the potential side effects?

Potential side effects include those typical of chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, nerve damage causing numbness or tingling sensations. Ruxolitinib may cause additional side effects like dizziness or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor or lymph node that meets the size requirements for measurement.

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My recent scans show advanced stage III or IV cancer.

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I have advanced ovarian, peritoneal, or fallopian tube cancer and plan to start chemotherapy before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study entry to time of progression or death, whichever occurs first, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study entry to time of progression or death, whichever occurs first, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry to time of progression or death, whichever occurs first, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting Toxicities (Phase I)

Progression-free Survival (PFS) (Phase II)

Secondary study objectives

Frequency of Patients Who Could Not Receive Surgery Within the Defined Timeframe for Reasons Other Than Non-response, Disease Progression, or Medical Contraindications (Phase I)

Number of Participants With Complete Pathological Response (Phase II)

Number of Participants With Grade 3 or Higher AE (Phase I and II)

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Other study objectives

Change in Cancer Stem Cells (CSC) Observed in Tissue

Change in Serum C-reactive Protein (CRP)