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

NCT05053750 | Active Not Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 2021-0694NCI-2021-10703
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epithelial Ovarian; Fallopian Tube; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (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

  through study completion, an average of 1 year

Study Arms (2)

Paclitaxel

EXPERIMENTAL

Drug: Paclitaxel/Bev (control)

Bevacizumab

EXPERIMENTAL

Drug: Paclitaxel/Bev + ZA (experimental)

Interventions

Paclitaxel/Bev (control) DRUG

Given by PO

Also known as: Taxol

Paclitaxel

Paclitaxel/Bev + ZA (experimental) DRUG

Given by PO

Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all the following criteria apply within 28 days of starting study treatment. be assessed
• 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.
• Hemoglobin ≥9.0 g/dL.
• Absolute neutrophil count (ANC) \> 1500/mm3
• Platelet count ≥100 x 109
• Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
• AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.
• Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply within 28 days of starting study treatment.
• 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.
• 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.
• Unstable cardiovascular function:
• ECG abnormalities requiring treatment, or
• congestive heart failure (CHF) of NYHA Class ≥3, or
• myocardial infarction (MI) within 3 months.
• Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study.
• Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); Known to be HIV seropositive

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Gateway for Cancer Research: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Shannon Westin

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 22, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)