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Anti-microtubule agent

Weekly Paclitaxel for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by Theradex

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cardiovascular: No New York Heart Association Class III or IV heart disease, No myocardial infarction within last 6 months, No congestive heart failure, No unstable angina, No clinically significant pericardial effusion or arrhythmia

Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well giving paclitaxel in different ways works in treating ovarian cancer.

Who is the study for?

This trial is for women over 18 with stage III or IV ovarian cancer that hasn't responded to initial chemo with paclitaxel and platinum. They should be relatively healthy, not pregnant, able to use birth control, and have no serious allergies to certain drugs. Their blood counts must meet specific levels, they shouldn't have severe heart issues or infections, and can't have had chemotherapy or radiation recently.Check my eligibility

What is being tested?

The study tests weekly infusions of the drug Paclitaxel in women whose ovarian cancer has stopped responding to standard treatments. It's a Phase II trial aiming to find out if changing the way Paclitaxel is given might make it more effective against tumor cells.See study design

What are the potential side effects?

Paclitaxel may cause side effects like allergic reactions (especially in those sensitive to Cremophor), low blood cell counts leading to increased infection risk or bleeding problems, fatigue, neuropathy (nerve pain or tingling), muscle pain, hair loss, nausea and other digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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My heart is generally healthy with no recent major issues.

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My ovarian cancer is advanced and didn't respond to initial chemo with platinum and paclitaxel.

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I have fallopian tube cancer.

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My cancer did not respond well or only temporarily responded to initial platinum and paclitaxel treatment.

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My cancer can be measured or seen on tests.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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My liver tests are within acceptable limits.

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My creatinine level is 2.0 mg/dL or lower.

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I do not have severe nerve pain or damage.

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My cancer originates in the lining of my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

TheradexLead Sponsor

33 Previous Clinical Trials

1,462 Total Patients Enrolled

Maurie Markman, MDStudy ChairThe Cleveland Clinic

2 Previous Clinical Trials

308 Total Patients Enrolled

2 Trials studying Ovarian Cancer

308 Patients Enrolled for Ovarian Cancer

Media Library

Paclitaxel (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT00003160 — Phase 2

Ovarian Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT00003160 — Phase 2

Paclitaxel (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003160 — Phase 2

Frequently Asked Questions

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

Has this medication received regulatory approval from the FDA?

"While there is some evidence from Phase 2 trials to support the safety of this treatment, there is no data yet to suggest that it is effective. Consequently, our team has given it a score of 2."

Answered by AI

Are people still welcome to sign up for this research project?

"This particular clinical trial is not presently recruiting patients, however, it is worth mentioning that 709 other trials are. This trial was initially posted on September 1st, 1997 and was last edited on April 19th, 2011."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

1997. "Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003160.

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