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Alkylating Agent

Paclitaxel 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
History/physical examination within 28 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.

Eligible Conditions
  • Ovarian Adenocarcinoma
  • Ovarian Cancer
  • Peritoneal Cancer
  • Peritoneal Serous Adenocarcinoma
  • Peritoneal Adenocarcinoma
  • Endometrioid Adenocarcinoma
  • Fallopian Tube Carcinoma
  • Fallopian Tube Cancer
  • Ovarian Carcinoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of hematologic (heme) dose-limiting toxicity (Phase I)
Secondary outcome measures
Complete pathological response (Phase II)
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)
Incidence of adverse events (Phase I)
+4 more
Other outcome measures
Change in cancer stem cells (CSC) observed in tissue
Change in serum C-reactive protein (CRP)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (ruxolitinib, paclitaxel, and carboplatin)Experimental Treatment4 Interventions
See Detailed Description.
Group II: Arm I (paclitaxel and carboplatin)Active Control3 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Ruxolitinib Phosphate
2011
Completed Phase 2
~390
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,677 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,499 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,708 Patients Enrolled for Ovarian Cancer
Robert A BurgerPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~18 spots leftby Mar 2025