Bevacizumab + Doxorubicin + Radiation for Sarcoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

Must not be taking: Anticoagulants, Anthracyclines

Disqualifiers: Metastatic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to test the safety, tolerability, maximum tolerated dose, and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy. Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to subjects with sarcoma who are enrolled in this research study and may only be administered under the direction of doctors who are investigators in this research study. This study is being done because sarcomas can recur after surgical resection (surgery for removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the same location as the original tumor or in distant sites such as the lung. Thus better treatments are needed. This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, combination of drugs, or combination of drugs with radiation. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs and radiation is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved bevacizumab with doxorubicin and radiation for your type of cancer.

Research Team

Edwin Choy, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with intermediate- or high-grade soft tissue sarcoma that can be surgically removed, located on limbs, trunk, or pelvis. The tumor must be at least 5 cm across or a local recurrence of any size without prior radiation. It's not for those with metastatic disease, pregnant/breastfeeding individuals, recent major surgery patients, people who have had doxorubicin/anthracycline chemotherapy/bevacizumab before, or those with certain medical conditions.

Inclusion Criteria

My cancer is a primary or locally recurrent soft tissue sarcoma and I haven't had radiation before.

My primary tumor is at least 5 cm wide or I have a local recurrence of any size.

My sarcoma is confirmed to be of intermediate or high severity.

Exclusion Criteria

I have not had a heart attack or any heart procedures in the last 6 months.

I have not had major surgery in the last 4 weeks.

I have a condition that makes my blood clot more than normal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive bevacizumab, metronomic doxorubicin, and radiation therapy

6 weeks

Weekly visits for drug administration and radiation therapy

Surgery

Surgical evaluation and potential removal of the tumor

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Annual follow-up calls

Treatment Details

Interventions

• Bevacizumab
• Doxorubicin
• Radiation Therapy

Trial Overview The study tests the safety and effectiveness of combining bevacizumab (a drug not yet approved for sarcomas) with doxorubicin chemotherapy and radiation therapy to find the maximum tolerated dose. As a Phase I clinical trial, it focuses on determining the right dosage for further research.

Participant Groups

Group I: Treatment Arm Experimental Treatment 3 Interventions

Bevacizumab, metronomic doxorubicin and radiation therapy

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+