- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053750
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Shannon Westin
- Phone Number: 713-794-4314
- Email: swestin@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
/L
- 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:
Creatinine CL (mL/min)
= Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Exclusion Criteria:
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
- Any underlying condition that would significantly interfere with the absorption of an oral medication.
- Grade >2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
- Patients with urine dipstick for proteinuria >2+. Patients with ≥2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate ≤1 g of protein in the 24-hour urine. Alternatively, proteinuria testing can be performed according to local standards.
- Serious psychiatric or medical conditions that could interfere with treatment;
- Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1
- Concurrent therapy with approved or investigational anticancer therapeutic other than steroids.
- Patients with coagulation problems and active bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)
- Patients with symptomatic brain lesions
- For women who are not postmenopausal (<12 months of non therapy-induced amenorrhea, with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus): agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non hormonal methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 4 months after the last dose of study drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paclitaxel
|
Given by PO
Other Names:
|
Experimental: Bevacizumab
|
Given by PO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shannon Westin, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Peritoneal Diseases
- Digestive System Neoplasms
- Abdominal Neoplasms
- Peritoneal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- 2021-0694
- NCI-2021-04298 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Peritoneal Cancer
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditions
-
University of Michigan Rogel Cancer CenterCompletedOvarian, Fallopian Tube, and Primary Peritoneal CancerUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Sanofi Pasteur, a Sanofi CompanyCompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIIA Primary... and other conditionsUnited States
-
Abramson Cancer Center at Penn MedicineRecruitingSuspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerUnited States
-
K-Group, Beta, Inc., a wholly owned subsidiary...RecruitingHigh-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal CancerUnited States, Australia, France
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIC Fallopian Tube Cancer and other conditionsCanada
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIB Ovarian Cancer | Stage IIIB Primary Peritoneal Cancer | Stage IIIC Fallopian Tube Cancer | Stage IIIC Ovarian Cancer | Stage IIIC Primary Peritoneal Cancer and other conditionsUnited States
-
OncoMed Pharmaceuticals, Inc.TerminatedPrimary Peritoneal CarcinomaUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIB Ovarian Cancer | Stage IIIB Primary Peritoneal Cancer | Stage IIIC Fallopian Tube Cancer | Stage IIIC Ovarian Cancer | Stage IIIC Primary Peritoneal Cancer and other conditions
Clinical Trials on Paclitaxel/Bev (control)
-
United States Army Research Institute of Environmental...Eastern Michigan UniversityCompletedWeight Loss | Other Effects of High AltitudeUnited States
-
Sun Yat-sen UniversityRecruitingMetastatic Microsatellite-stable Colorectal CancerChina
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Cancer Institute and Hospital, Chinese Academy...RecruitingGastric Cancer | Diffuse Type CarcinomaChina
-
Peking University Cancer Hospital & InstituteUnknown
-
CTI BioPharmaTerminated
-
Sharon SteinMerck Sharp & Dohme LLCTerminated
-
CTI BioPharmaWithdrawn
-
Tianjin Medical University Cancer Institute and...RecruitingGastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)China
-
Second Affiliated Hospital of Guangzhou Medical...First People's Hospital of Foshan; Affiliated Cancer Hospital & Institute of... and other collaboratorsRecruitingHepatocellular Carcinoma Non-resectableChina