Bevacizumab/Doxorubicin/Radiation for Sarcoma (NCT01746238) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Bevacizumab/Doxorubicin/Radiation for Sarcoma
United States14 participantsStarted 2013-03
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary soft tissue sarcoma or isolated local recurrent sarcoma without prior radiation
* Histologically intermediate- or high-grade soft tissue sarcoma
* Determined by an expert sarcoma surgeon to have resectable disease located on the upper extremity, lower extremity, trunk, retroperitoneum or pelvis
* Primary tumor must be at least 5 cm in maximal diameter or an isolated local recurrence of any size
Exclusion Criteria:
* Metastatic disease
* Pregnant or breastfeeding
* Immunotherapy, chemotherapy, experimental therapy or radiotherapy within 4 weeks of first day of study drug dosing
* Previously received doxorubicin, any other anthracycline chemotherapy or bevacizumab
* Major surgery within 4 weeks before first day of study drug dosing
* Uncontrolled intercurrent illness
* History of myocardial infarction, acute coronary syndromes, coronary angioplasty or coronary artery stenting within previous 6 months
* Other medical or psychiatric conditions that may interfere with study participation
* Known hypercoagulable disorder
* Known history of deep vein thrombosis or pulmonary embolus
* Presence of bleeding diathesis or coagulopathy
* Current use of therapeutic anticoagulants
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine MTD of bevacizumab+doxorubicin+radiation