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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
Be older than 18 years old
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 Cancer
- Peritoneal Cancer
- Endometrioid Adenocarcinoma
- Peritoneal Adenocarcinoma
- Fallopian Tube Carcinoma
- Fallopian Tube Cancer
- Ovarian Carcinoma
- Ovarian Adenocarcinoma
- Peritoneal Serous Adenocarcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreOther 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
~9870
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
232 Previous Clinical Trials
101,042 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,603 Total Patients Enrolled
288 Trials studying Ovarian Cancer
73,651 Patients Enrolled for Ovarian Cancer
Robert A BurgerPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
30 Total Patients Enrolled
Frequently Asked Questions
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