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Monoclonal Antibodies

Paclitaxel for Fallopian Tube Cancer

Phase 2

Waitlist Available

Led By Saravut Weroha

Research Sponsored by Mayo Clinic

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 3 years

Awards & highlights

Study Summary

This trial is testing how well different chemotherapy drugs work on ovarian, primary peritoneal, or fallopian tube cancer that has resisted platinum drugs, using an Avatar to guide treatment.

Eligible Conditions

Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Proportion of patients with a confirmed tumor response, defined as complete response or partial response estimated using Response Evaluation Criteria in Solid Tumors 1.1 criteria

Secondary outcome measures

Incidence of adverse events (AE)

Overall survival (OS)

Progression free survival (PFS)

+1 more

Other outcome measures

Enriched Avatar response signature in response to Avatar-directed therapy using patient outcomes

Frequency (%) of patients who had an Avatar response and a clinical tumor response for the same treatment

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (Avatar-directed topotecan hydrochloride)Experimental Treatment2 Interventions

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (Avatar-directed liposomal doxorubicin)Experimental Treatment2 Interventions

Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm B (Avatar-directed gemcitabine hydrochloride)Experimental Treatment1 Intervention

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (Avatar-directed paclitaxel)Experimental Treatment2 Interventions

Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Pegylated Liposomal Doxorubicin Hydrochloride

2001

Completed Phase 3

~4520

Bevacizumab

2013

Completed Phase 4

~5280

Topotecan Hydrochloride

2013

Completed Phase 3

~6120

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,474 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,127 Total Patients Enrolled

Saravut WerohaPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its blessing to Paclitaxel?

"By and large, Paclitaxel has only been studied to a limited degree in regards to its safety; thus, it was assigned an overall score of 2."

Answered by AI

Are there any vacancies remaining in this research project?

"According to the clinicaltrials.gov portal, this research is actively recruiting participants and has been since July 21st 2015. The page was most recently updated on June 27th 2022."

Answered by AI

How many individuals are currently participating in this experiment?

"Affirmative. The clinicaltrials.gov site confirms that this medical trial, which was initially posted on July 21st 2015, is looking for new participants. A total of 240 individuals must be recruited from 3 separate research sites."

Answered by AI

For which medical conditions is Paclitaxel employed most frequently?

"Paclitaxel is typically used to combat typhus, but it has also been utilized for the management of kaposi's sarcoma in AIDS patients, helicobacter pylori infection, and recurrent cervical cancer."

Answered by AI

Is this study pioneering a new area of medical research?

"Alfacell's 1997 study of Paclitaxel, which had 300 participants, marked the start of its clinical journey. Following this pilot research project and subsequent Phase 3 drug approval, 1720 active studies concerning Paclitaxel have been conducted across 91 countries and 3805 cities."

Answered by AI

What other investigations have been carried out concerning Paclitaxel?

"Paclitaxel was first tested in a clinical setting at Spectrum Health Hospital - Butterworth Campus back in 1997. Since then, there have been 3347 completed trials and 1720 active studies still underway; many of which are located near Jacksonville, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

2015. "Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02312245.