Trials / Active Not Recruiting
Active Not RecruitingNCT05053750
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
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized pilot trial of weekly paclitaxel and bevacizumab with or without zoledronic acid in women with platinum-resistant epithelial ovarian cancer with 1-2 prior regimens for recurrence.
Detailed description
Primary Objective: -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. The primary endpoint is the percentage changes in macrophage count from baseline to after 2 cycles of therapy. Secondary Objective: * To estimate the progression free survival (PFS) of combination weekly paclitaxel/bevacizumab and ZA relative to weekly paclitaxel/bevacizumab in women with platinum-resistant recurrent ovarian cancer * To evaluate toxicity of the two arms * To assess objective response and duration of response by RECIST 1.1 * To estimate overall survival Exploratory Objective To assess differential effects from baseline, within and between patient treatment cohorts, on macrophage and hypoxia markers, CSF1/R and MHCII, plasma biomarker (VEGF, VEGFR, IL6, IL8, FGF, PDGFAA), tumor and macrophage-derived exosomes, and single-cell level changes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel/Bev (control) | Given by PO |
| DRUG | Paclitaxel/Bev + ZA (experimental) | Given by PO |
Timeline
- Start date
- 2021-12-14
- Primary completion
- 2027-02-02
- Completion
- 2027-02-02
- First posted
- 2021-09-22
- Last updated
- 2026-04-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05053750. Inclusion in this directory is not an endorsement.