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Monoclonal Antibodies

Chemotherapy + Targeted Therapy for Recurrent Ovarian Cancer

Phase < 1
Waitlist Available
Led By Shannon Westin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed and documented platinum refractory or platinum resistant high grade epithelial ovarian cancer
Age ≥ 18 years at time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat ovarian cancer that has returned after treatment.

Who is the study for?
This trial is for women over 18 with recurrent, platinum-resistant epithelial ovarian cancer who've had 1-2 prior treatments. They must have good performance status and organ function, not be pregnant or breastfeeding, and have no other active cancers or recent major surgeries. Participants should not have received certain therapies recently and must agree to contraception if applicable.Check my eligibility
What is being tested?
The study compares weekly paclitaxel and bevacizumab (control) against the same regimen plus zoledronic acid (experimental) in women with specific types of ovarian cancer that's resistant to platinum-based chemotherapy. It's a randomized pilot trial where patients are assigned by chance to either group.See study design
What are the potential side effects?
Possible side effects include allergic reactions, lowered blood cell counts increasing infection risk, fatigue, potential kidney issues due to creatinine clearance requirements, nerve damage symptoms like numbness or tingling (neuropathy), and increased risk of bleeding or cardiovascular problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian cancer is resistant to platinum-based chemotherapy.
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I am 18 years old or older.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess macrophage counts by image cytometry in women with platinum resistant ovarian cancer treated with weekly paclitaxel/bevacizumab and ZA relative to weekly paclitaxel/bevacizumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: PaclitaxelExperimental Treatment1 Intervention
Group II: BevacizumabExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,767 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,556 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,139 Total Patients Enrolled

Frequently Asked Questions

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

Is this trial currently recruiting participants?

"According to clinicaltrials.gov, this medical research is currently enrolling participants as of August 9th 2022 since its initial post on December 14th 2021."

Answered by AI

What conditions does the combination of Paclitaxel/Bev and ZA (experimental) commonly address?

"Paclitaxel/Bev + ZA (experimental) is frequently administered to treat recurrent platinum-sensitive epithelial ovarian cancer. However, this remedy has also been seen as effective for other malignant neoplasms, persistent cervical cancer, and recurrent cervical cancer."

Answered by AI

How many patients have registered to participate in this experiment?

"Yes, according to the research hosted on clinicaltrials.gov this medical trial is actively looking for participants. The study was initially posted in December 2021 and recently edited in August 2022. 30 individuals are required from 1 location to complete enrollment criteria."

Answered by AI

Have any other experiments been conducted using Paclitaxel/Bev + ZA?

"Presently, there are 1129 ongoing clinical trials assessing Paclitaxel/Bev + ZA (experimental), 295 of which have entered Phase 3. Shanghai is the primary location for these studies, though 57726 different sites across the globe are running tests related to this experimental treatment."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
TAME: A Pilot Study of Weekly Paclitaxel, Bevacizumab, and Tumor Associated Macrophage Targeted Therapy (Zoledronic Acid) in Women With Recurrent, Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
2021. "TAME: A Pilot Study of Weekly Paclitaxel, Bevacizumab, and Tumor Associated Macrophage Targeted Therapy (Zoledronic Acid) in Women With Recurrent, Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05053750.
All > Peritoneal Carcinomatosis
~8 spots leftby Feb 2027
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