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AOST2032: Cabozantinib with Chemotherapy for Osteosarcoma

About this study

In this study, we want to learn how to better treat the bone cancer osteosarcoma. It is usually treated with surgery and a combination of 3 chemotherapy drugs called “MAP” (methotrexate, doxorubicin, and cisplatin).

We want to find out if adding a new drug, cabozantinib, to this therapy will treat osteosarcoma better. We do not know whether adding cabozantinib will improve the outcome.

Part 1 of this trial will study whether cabozantinib and MAP therapy is safe without bad side effects. We hope to find the highest and safest dose of cabozantinib that we can use with MAP therapy.

In parts 2 and 3 of this study, we will compare any side effects of using cabozantinib along with the MAP chemotherapy and surgery.

Patients will be put into 2 groups:

  • Those who get MAP chemotherapy and surgery to remove the tumor
  • Those who get cabozantinib along with MAP chemotherapy and surgery

The effects of treatment from both groups will be compared to see which group does better.

Eligibility overview

  • Less than 40 years old
  • A new diagnosis of high-grade osteosarcoma

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Overview

Full title:

A Feasibility and Randomized Phase 2/3 Study of the VEGFR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

Study goal:

Find the highest dose of cabozantinib that can be given safely along with MAP chemotherapy; compare the effects of cabozantinib along with MAP and surgery versus MAP and surgery alone to find out which is better.

Diagnosis:

Osteosarcoma

Age:

Less than 40 years old

Clinical trials categories:

Childhood Cancer Osteosarcoma Solid Tumors

For physicians and researchers

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