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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
Must not have
Nonepithelial tumors including carcinosarcomas, Mucinous ovarian cancers, Ovarian tumors with low malignant potential or low-grade epithelial tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
My ovarian cancer is resistant to platinum-based chemotherapy.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My ovarian cancer is not the common type and includes specific rare forms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: PaclitaxelExperimental Treatment1 Intervention
Group II: BevacizumabExperimental Treatment1 Intervention
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,062 Previous Clinical Trials
1,800,737 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,468 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,012,009 Total Patients Enrolled
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