TAME: A Pilot Study of Weekly Paclitaxel, Bevacizumab, and Tumor Associated Macrophage Targeted T… (NCT05053750) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
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
United States14 participantsStarted 2021-12-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ability to provide signed informed consent
✓. Age ≥ 18 years at time of study entry
✓. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
✓. Histologically confirmed and documented platinum refractory\* or platinum resistant\*\* high grade epithelial ovarian cancer to include: adenocarcinoma NOS, clear cell adenocarcinoma, endometrioid adenocarcinoma, malignant Brenner's tumor, mixed epithelial carcinoma, serous adenocarcinoma, transitional cell carcinoma, and undifferentiated carcinoma. \* Platinum refractory is defined as progression during platinum-containing therapy or within 4 weeks of last dose. \*\* Platinum resistant is defined as relapse-free interval 1-6 months of a platinum-containing therapy
✓. Prior Therapy: Unlimited prior systemic therapies are allowed.
✓. ECOG performance status of 0-1
✓. Life expectancy \> 12 weeks
✓. Adequate normal organ and marrow function as defined below.
Exclusion criteria
✕. Nonepithelial tumors including carcinosarcomas. Mucinous ovarian cancers. Ovarian tumors with low malignant potential or low-grade epithelial tumors.
✕. Patients who have received anti-VEGF targeted therapy (alone or in combination with chemotherapy or other biological agents) for recurrent disease and have progressed on that therapy or within 6 months of discontinuation of that therapy. Prior bevacizumab in the upfront setting is permitted.
What they're measuring
1
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
Timeframe: through study completion, an average of 1 year
✕. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast, or early stage endometrial cancer (stage IA/B, Grade 1 or 2, endometrioid histology).
✕. Patients with known or suspected conditions likely to increase gastrointestinal toxicity, such as, inflammatory bowel disease, bowel obstruction, history of bowel obstruction or overt bowel involvement by tumor.
✕. History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
✕. Patients who are pregnant or lactating.
✕. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.
✕. Major surgery (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within four weeks before Day 1.