Study Summary
This trial tests if a drug (cabozantinib) combined with 3 chemo drugs (methotrexate, doxorubicin, cisplatin) can treat newly diagnosed osteosarcoma better than chemo alone.
Eligible Conditions
- Osteosarcoma
- Secondary Osteosarcoma
- Localized Osteosarcoma
- Metastatic Bone Sarcoma
- Unresectable Osteosarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: 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
Week 6
Occurrence of dose-limiting toxicity (DLT) (Feasibility)
Year 5
Overall survival (OS)
Year 5
Event-free survival (EFS) (Phase II)
Event-free survival (EFS) (Phase III)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
5 Treatment Groups
Efficacy Phase Arm C (MAP)
1 of 5
Efficacy Phase Arm A (MAP)
1 of 5
Efficacy Phase Arm B (cabozantinib, MAP)
1 of 5
Efficacy Phase Arm D (cabozantinib, MAP)
1 of 5
Feasibility phase (cabozantinib, MAP)
1 of 5
Active Control
Experimental Treatment
1122 Total Participants · 5 Treatment Groups
Primary Treatment: Efficacy Phase Arm B (cabozantinib, MAP) · No Placebo Group · Phase 2 & 3
Efficacy Phase Arm B (cabozantinib, MAP)Experimental Group · 9 Interventions: Surgical Procedure, Computed Tomography, Bone Scan, Cabozantinib S-malate, Magnetic Resonance Imaging, Doxorubicin Hydrochloride, Cisplatin, Methotrexate, X-Ray Imaging · Intervention Types: Procedure, Procedure, Procedure, Drug, Procedure, Drug, Drug, Drug, Procedure
Efficacy Phase Arm D (cabozantinib, MAP)Experimental Group · 8 Interventions: Computed Tomography, Bone Scan, Cabozantinib S-malate, Magnetic Resonance Imaging, Doxorubicin Hydrochloride, Cisplatin, Methotrexate, X-Ray Imaging · Intervention Types: Procedure, Procedure, Drug, Procedure, Drug, Drug, Drug, Procedure
Feasibility phase (cabozantinib, MAP)Experimental Group · 9 Interventions: Surgical Procedure, Computed Tomography, Bone Scan, Cabozantinib S-malate, Magnetic Resonance Imaging, Doxorubicin Hydrochloride, Cisplatin, Methotrexate, X-Ray Imaging · Intervention Types: Procedure, Procedure, Procedure, Drug, Procedure, Drug, Drug, Drug, Procedure
Efficacy Phase Arm C (MAP)ActiveComparator Group · 8 Interventions: Surgical Procedure, Computed Tomography, Bone Scan, Magnetic Resonance Imaging, Doxorubicin Hydrochloride, Cisplatin, Methotrexate, X-Ray Imaging · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Drug, Drug, Procedure
Efficacy Phase Arm A (MAP)ActiveComparator Group · 8 Interventions: Surgical Procedure, Computed Tomography, Bone Scan, Magnetic Resonance Imaging, Doxorubicin Hydrochloride, Cisplatin, Methotrexate, X-Ray Imaging · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Drug, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Procedure
2016
Completed Phase 2
~110
Computed Tomography
2017
Completed Phase 2
~3410
Cabozantinib S-malate
2013
Completed Phase 2
~470
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Doxorubicin Hydrochloride
2010
Completed Phase 3
~17370
Cisplatin
2013
Completed Phase 3
~1920
Methotrexate
2013
Completed Phase 4
~3800
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,153 Previous Clinical Trials
41,161,699 Total Patients Enrolled
101 Trials studying Osteosarcoma
20,145 Patients Enrolled for Osteosarcoma
Michael W BishopPrincipal InvestigatorChildren's Oncology Group
Eligibility Criteria
Age < 65 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be younger than 40 years old when you join the study.
You need to be a certain size to participate, which means you must have a body surface area of at least 0.8 square meters.
You have a type of bone cancer called osteosarcoma that started in a bone other than your pelvis. Your medical team thinks they can remove the cancer with surgery and they haven't found any signs that it has spread elsewhere in your body.
You have been diagnosed with high grade osteosarcoma by a doctor. This can be a primary tumor located in any part of your body. If you have had osteosarcoma before, you can still participate as long as you have not received chemotherapy treatment for it.
You have cancer that has spread to other parts of your body and a tumor that can be surgically removed. A team of doctors will decide if your tumor can be removed.
Cancer cells have spread to other areas of your body, except for nearby lymph nodes or bones close to the main tumor. If cancer cells have spread to a bone next to the main tumor, it is considered a bone metastasis.
The study is in the later stages of testing to determine if the treatment works.
You have a cancerous tumor in your pelvis that cannot be removed by surgery or has spread to other parts of your body according to imaging tests.
You have cancer that has spread to your lungs, as confirmed by a biopsy or imaging showing one or more lesions that are at least 5mm in size, or multiple lesions that are 3mm or larger.
If you have possible bone metastases based on a PET scan, you need to have a biopsy or additional imaging, such as an MRI or CT scan, to confirm.
Frequently Asked Questions
How many health care facilities are presently administering this experiment?
"Patients can enroll in this study at ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital in Toledo, Saint Jude Children's Research Hospital in Memphis, Marshfield Medical Center-Marshfield in Marshfield and a few other facilities." - Anonymous Online Contributor
Unverified Answer
What is the capacity of participants for this medical experiment?
"To conduct this trial, 1122 volunteers meeting the criteria must be enrolled. In particular, ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital in Toledo and St Jude Children’s Research Hospital in Memphis are accepting participants." - Anonymous Online Contributor
Unverified Answer