A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination With Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to standard MAP (high dose methotrexate, doxorubicin hydrochloride [doxorubicin], and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor.
II. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with localized, resectable osteosarcoma.
III. To determine whether MAP chemotherapy plus cabozantinib results in more favorable event-free survival (EFS) than MAP chemotherapy alone in patients with metastatic, pelvic and unresectable osteosarcoma.
SECONDARY OBJECTIVES:
I. To determine whether MAP chemotherapy plus cabozantinib results in more favorable overall survival (OS) than MAP chemotherapy alone in patients with localized, resectable osteosarcoma.
II. To determine whether MAP chemotherapy plus cabozantinib results in more favorable overall survival (OS) than MAP chemotherapy alone in patients with metastatic, pelvic and unresectable osteosarcoma.
EXPLORATORY OBJECTIVES:
I. To determine the rate of good histologic response (> 90%) of resected primary tumor specimens following neoadjuvant chemotherapy with MAP plus cabozantinib and compare with response rates for MAP chemotherapy alone.
II. To describe the toxicities of the addition of cabozantinib to MAP chemotherapy in patients with newly diagnosed osteosarcoma.
III. To describe frequency of application of local control methods (surgery, hypofractionated stereotactic body radiotherapy, or radiofrequency ablation) for extrapulmonary metastatic osteosarcoma.
IV. To compare total cumulative delivered doses of MAP chemotherapy agents between standard and experimental arms across multiple phases of therapy.
V. To assess the pharmacokinetics of cabozantinib when administered concomitantly with standard chemotherapy agents during feasibility.
VI. To collect pulmonary metastatic lesions, paired primary tumor tissue, and serial blood samples for tumor profiling, liquid biopsies, and future testing of correlative biology studies.
OUTLINE: This is a dose-escalation study of cabozantinib (Feasibility Phase) followed by a randomized phase II/III study (Efficacy Phase).
FEASIBILITY PHASE: Patients receive cabozantinib orally (PO), methotrexate intravenously (IV), doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles. Patients then receive methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle, followed by cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle. Next, patients receive cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional "consolidation" cycles. Patients then receive cabozantinib PO for six 28-day "maintenance" cycles.
EFFICACY PHASE: Patients with standard risk osteosarcoma are randomized to Arm A or Arm B. Patients with high risk osteosarcoma are randomized to Arm C or Arm D.
ARM A: Patients receive methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by two 35-day "consolidation" cycles. Next, patients receive methotrexate IV and doxorubicin IV for two additional 35-day "consolidation" cycles.
ARM B: Patients receive cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by two 35-day "consolidation" cycles. Next, patients receive cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional 35-day "consolidation" cycles. Patients then receive cabozantinib PO for six 28-day "maintenance" cycles.
ARM C: Patients receive methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by two 35-day "consolidation" cycles. Next, patients receive methotrexate IV and doxorubicin IV for two additional 35-day "consolidation" cycles.
ARM D: Patients receive cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles. Patients then receive methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle, followed by cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle. Next, patients receive cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional "consolidation" cycles. Patients then receive cabozantinib PO for six 28-day "maintenance" cycles.
All patients also undergo X-ray, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), bone scintigraphy throughout the trial. All patients also undergo collection of blood samples during screening and on study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must be < 40 years of age at the time of enrollment.
- Patients must have a body surface area of >= 0.8 m^2 at the time of enrollment.
- Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.
- Feasibility Phase:
Patients must have metastatic disease and a resectable primary tumor. Designation of a primary tumor as resectable will be determined at the time of diagnosis by the institutional multidisciplinary team.
For this study, metastatic disease is defined as one or more of the following:
- Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases.
- Lung metastases: defined as biopsy-proven metastasis or the presence of one or more pulmonary lesions >= 5 mm, OR multiple pulmonary lesions >= 3 mm or greater in size.
Bone metastases: Areas suspicious for bone metastasis based on fludeoxyglucose F-18 (18F-FDG)-positron emission tomography (PET) scan (or whole body technetium-99 bone scan if 18F-FDG-PET is unavailable at the treating institution) require confirmatory biopsy or supportive anatomic imaging of at least one suspicious site with either magnetic resonance imaging (MRI) or computed tomography (CT) (whole body 18F-FDG-PET/CT or 18F-FDG-PET/MR scans are acceptable).
- Efficacy Phases (Phase 2/3)
Patients with both localized and metastatic disease are eligible for the efficacy phase, regardless of resectability. Patients will be enrolled to two separate cohorts:
- Cohort 1 (Standard Risk): Patients with non-pelvic primary osteosarcoma deemed to be resectable at the time of diagnosis by the institutional multidisciplinary team, without evidence of metastatic lesions.
Cohort 2 (High-Risk): Patients with a primary pelvic tumor, a primary tumor designated as unresectable by the institutional multidisciplinary team, AND/OR radiographic evidence of metastatic lesions.
• Adequate renal function defined as:
- A serum creatinine based on age/gender as follows:
(Age: Maximum Serum Creatinine [mg/dL]; Gender)
- 1 month to < 6 months: 0.4 (male); 0.4 (female)
- 6 months to < 1 year: 0.5 (male); 0.5 (female)
- 1 to < 2 years: 0.6 (male); 0.6 (female)
- 2 to < 6 years: 0.8 (male); 0.8 (female)
- 6 to < 10 years: 1 (male); 1 (female)
- 10 to < 13 years: 1.2 (male); 1.2 (female)
- 13 to < 16 years: 1.5 (male); 1.4 (female)
- >= 16 years: 1.7 (male); 1.4 (female)
- OR - a 24 hour urine creatinine clearance >= 70 mL/min/1.73 m^2
OR - a glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).
** Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L
Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
• Adequate cardiac function defined as:
- No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias or
- Shortening fraction of >= 27%, or
- Ejection fraction of >= 50%, or
Corrected QT interval by Fridericia (QTcF) < 480 msec on electrocardiogram. Patients with Grade 1 prolonged QTc (450-480 msec) at time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications).
- Peripheral absolute neutrophil count (ANC) >= 1000/uL
- Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment
- Hemoglobin >= 8.0 g/dL
- International normalized ratio (INR) =< 1.5
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4, CYP2D6, and/or MRP2 transporter protein.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
- Patients who have received previous systemic therapy for osteosarcoma or a prior oncologic diagnosis.
- Patients who have central nervous system metastases.
- Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung.
- Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
- Patients with gastrointestinal disorders including active disorders associated with a high risk of perforation or fistula formation. Specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, bowel obstruction, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment.
- Patients with active bleeding or bleeding diathesis. No clinically significant hematuria, hematemesis, or hemoptysis or other history of significant bleeding within 3 months prior to enrollment.
- Patients with uncompensated or symptomatic hypothyroidism. Patients who have hypothyroidism controlled with thyroid replacement hormone are eligible.
- Patients with moderate to severe hepatic impairment (Child-Pugh B or C).
- Patients who have had primary tumor resection or attempted curative resection of metastases prior to enrollment.
- Patients who have undergone other major surgical procedure (eg, laparotomy) within 14 days prior to enrollment. Thoracoscopic procedures for diagnostic purposes (biopsy of lung nodule) and central access such as port-a-cath placement are allowed.
- Patients with a history of serious or non-healing wound or bone fracture (pathologic fracture of primary tumor is not considered exclusion).
- Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of cabozantinib.
- Patients with previously identify allergy or hypersensitivity to components of the study treatment formulations.
- Patients who are receiving any other investigational agent not defined within this protocol are not eligible.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Patients received enzyme-inducing anticonvulsants within 14 days prior to enrollment.
- Patients with a prior history of hypertension (> 95th percentile for age, height, and gender for patients < 18 years and > 140/90 mmHg for patients >= 18 years requiring medication for blood pressure control.
- Patients who are receiving drugs that prolong QTc.
- Patients receiving anticoagulation with oral coumarin agents (eg warfarin), direct thrombin inhibitors (eg dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (eg, clopidogrel). Low dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH and direct factor Xa inhibitors rivaroxaban or apixaban are allowed in subjects who are on a stable dose for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen.
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants.
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feasibility phase (cabozantinib, MAP)
Patients receive cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles.
Patients then receive methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle, followed by cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle.
Next, patients receive cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional "consolidation" cycles.
Patients then receive cabozantinib PO for six 28-day "maintenance" cycles.
All patients also undergo X-ray, CT, MRI, PET, and bone scintigraphy scans throughout the trial.
All patients also undergo collection of blood samples during screening and on study.
|
Undergo MRI
Given IV
Other Names:
Undergo CT
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo X-ray
Undergo bone scintography
|
|
Active Comparator: Efficacy Phase Arm A (MAP)
Patients with standard risk osteosarcoma receive methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by two 35-day "consolidation" cycles.
Next, patients receive methotrexate IV and doxorubicin IV for two additional 35-day "consolidation" cycles.
All patients also undergo X-ray, CT, MRI, PET, and bone scintigraphy scans throughout the trial.
All patients also undergo collection of blood samples during screening and on study.
|
Undergo MRI
Given IV
Other Names:
Undergo CT
Given IV
Other Names:
Given IV
Other Names:
Undergo X-ray
Undergo bone scintography
|
|
Experimental: Efficacy Phase Arm B (cabozantinib, MAP)
Patients with standard risk osteosarcoma receive cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by two 35-day "consolidation" cycles.
Next, patients receive cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional 35-day "consolidation" cycles.
Patients then receive cabozantinib PO for six 28-day "maintenance" cycles.
All patients also undergo X-ray, CT, MRI, PET, and bone scintigraphy scans throughout the trial.
All patients also undergo collection of blood samples during screening and on study.
|
Undergo MRI
Given IV
Other Names:
Undergo CT
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo X-ray
Undergo bone scintography
|
|
Active Comparator: Efficacy Phase Arm C (MAP)
Patients with high risk osteosarcoma receive methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles, followed by two 35-day "consolidation" cycles.
Next, patients receive methotrexate IV and doxorubicin IV for two additional 35-day "consolidation" cycles.
All patients also undergo X-ray, CT, MRI, PET, and bone scintigraphy scans throughout the trial.
All patients also undergo collection of blood samples during screening and on study.
|
Undergo MRI
Given IV
Other Names:
Undergo CT
Given IV
Other Names:
Given IV
Other Names:
Undergo X-ray
Undergo bone scintography
|
|
Experimental: Efficacy Phase Arm D (cabozantinib, MAP)
Patients with high risk osteosarcoma receive cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles.
Patients then receive methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle, followed by cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day "consolidation" cycle.
Next, patients receive cabozantinib PO, methotrexate IV, and doxorubicin IV for two additional "consolidation" cycles.
Patients then receive cabozantinib PO for six 28-day "maintenance" cycles.
All patients also undergo X-ray, CT, MRI, PET, and bone scintigraphy scans throughout the trial.
All patients also undergo collection of blood samples during screening and on study.
|
Undergo MRI
Given IV
Other Names:
Undergo CT
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Undergo X-ray
Undergo bone scintography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of dose-limiting toxicity (DLT) (Feasibility)
Time Frame: Baseline up to 6 weeks
|
Occurrence of dose-limiting toxicity (DLT) (Feasibility) Only patients with high risk osteosarcoma who have a primary tumor considered resectable at the time of enrollment will be enrolled to this part of the trial.
If a feasible dose cannot be established, the study committee will consult with Children's Oncology Group (COG) leadership and National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) regarding possible modifications of the regimen and subsequent protocol amendment.
Baseline up to 6 weeks
|
Baseline up to 6 weeks
|
|
Event-free survival (EFS) (Phase II)
Time Frame: From randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
|
The randomization and analysis will be stratified according to risk group.
An assessment of the reduction in risk for EFS-event at the designated landmark time will be used to determine whether the trial continues to part 3.
If the study proceeds to part 3, patients enrolled to part 2 of the trial will contribute to the primary analyses for part 3 of the study.
If the interim criterion for continuation is not obtained, accrual will be closed with the conclusion that cabozantinib does not reduce sufficiently the risk for EFS-event for patients with newly-diagnosed osteosarcoma.
|
From randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
|
|
Event-free survival (EFS) (Phase III)
Time Frame: From randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
|
The number of patients with event-free survival (EFS) from enrollment and EFS status at last EFS follow-up.
EFS is defined as the time from randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first.
Will consist of two randomized phase 3 sub-studies ('Phase 3').
One will be conducted in standard risk patients and one will be conducted in high risk patients.
|
From randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: From randomization until death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
|
The number of patients with overall survival (OS) from enrollment and life status at last OS follow-up.
OS is defined as the time from randomization until death or last contact, whichever occurs first.
|
From randomization until death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Sarcoma
- Osteosarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Cisplatin
- Doxorubicin
- Liposomal doxorubicin
- Methotrexate
Other Study ID Numbers
- AOST2032 (Other Identifier: CTEP)
- NCI-2022-08567 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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