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Alkylating agents

Paclitaxel for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by University of Miami

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 48 months

Awards & highlights

Study Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to standard chemotherapy can help treat people with advanced lung cancer.

Eligible Conditions

Ovarian Cancer
Peritoneal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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

Pathologic Objective Response Rate (pORR) in Participants Receiving Protocol Therapy

Secondary outcome measures

Number of Participants Experiencing Treatment-related Toxicity

Progression-Free Survival (PFS)

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

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab, Paclitaxel + CarboplatinExperimental Treatment3 Interventions

The following therapy will be administered during each 21-day cycle for a maximum of eight (8) cycles: Pembrolizumab 200mg intravenously (IV); Paclitaxel 175 mg/m2 IV in a neoadjuvant setting (NACT); Paclitaxel same as NACT, OR 80 mg/m2 IV dose dense option in an adjuvant setting (ACT); Carboplatin IV area under the curve (AUC) of 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,050 Total Patients Enrolled

3 Trials studying Ovarian Cancer

492 Patients Enrolled for Ovarian Cancer

Marilyn Huang, MD, MSLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,120 Total Patients Enrolled

42 Trials studying Ovarian Cancer

6,600 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.

What maladies does Paclitaxel typically ameliorate?

"Paclitaxel is often employed to tackle malignant neoplasms, and also has a proven track record with regards to treating unresectable melanoma, microsatellite instability high cases, and patients at risk of recurrence."

Answered by AI

Has the Federal Drug Administration (FDA) sanctioned Paclitaxel?

"Paclitaxel is evaluated at a score of 2, as this Phase 2 trial provides evidence for safety but not efficacy."

Answered by AI

What is the maximum capacity for participants in this medical trial?

"This experiment is no longer enrolling patients. It was first listed on 12/22/2016 and last modified on 9/2/2022. However, there are currently 572 trials looking for individuals with fallopian tubes cancer, while 1988 studies require participants to utilize Paclitaxel as part of their treatment regimen."

Answered by AI

Are there any vacancies left for those interested in participating in this clinical trial?

"Sadly, no more patients are being enrolled in this clinical trial. The original post was published on December 22nd 2016 and the final update occured on September 2nd 2022. However, if you're looking for other trials there are currently 572 studies that accept participants with fallopian tube cancer and 1988 related to Paclitaxel."

Answered by AI

What prior experiments involving Paclitaxel have generated noteworthy outcomes?

"Currently, 1988 medical studies are researching Paclitaxel with 413 of them in the concluding Phase 3. Shanghai is one of many cities that have trials for this medication; globally there are 91452 sites conducting research into its usage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).

Abdulrahman Sinno, MD 2016. "Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02834975.