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Anti-metabolites

Paclitaxel for Ovarian Cancer

Phase 2
Waitlist Available
Led By Robert Wenham, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 36 months
Awards & highlights

Study Summary

This trial is testing a combination of two drugs to treat cancer, to see if it is more effective than one of the drugs alone, and if it is safe.

Eligible Conditions
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Adverse Events
Progression-free Survival (PFS) at 6 Months
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Median Overall Survival (OS)
+1 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment2 Interventions
Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,450 Total Patients Enrolled
10 Trials studying Ovarian Cancer
575 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,015 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,558 Patients Enrolled for Ovarian Cancer
Robert Wenham, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
3 Previous Clinical Trials
71 Total Patients Enrolled
2 Trials studying Ovarian Cancer
52 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer
2015. "Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02440425.
~4 spots leftby Apr 2025
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