Study on Chemotherapy With or Without Bevacizumab for Treating Recurrent or Metastatic Head and Neck Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00588770
This clinical trial is exploring whether adding the drug bevacizumab to standard chemotherapy can improve treatment outcomes for patients with head and neck cancer that has returned or spread to other parts of the body.
Patient Parameters
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Program Overview
This study is investigating if combining the drug bevacizumab with standard chemotherapy can help treat head and neck squamous cell carcinoma that has come back or spread. Chemotherapy drugs like docetaxel, cisplatin, carboplatin, and fluorouracil work by stopping cancer cells from growing and spreading. Bevacizumab is a monoclonal antibody that may help make cancer cells more sensitive to chemotherapy and block blood flow to tumors, potentially improving treatment effectiveness. The study aims to find out if this combination is more effective than chemotherapy alone.
Description
The main goal of this study is to compare the survival rates of patients with recurrent or metastatic head and neck cancer who receive standard chemotherapy with or without the addition of bevacizumab. Researchers will also look at the side effects of adding bevacizumab to different chemotherapy combinations and measure how well the cancer responds to these treatments. Blood and tumor samples will be collected for future research.
Participants will be randomly assigned to one of two groups for their chemotherapy treatment:
- Group 1: Receives chemotherapy with docetaxel and cisplatin every 21 days.
- Group 2: Receives the same chemotherapy as Group 1, plus bevacizumab.
Other groups will receive different combinations of chemotherapy drugs, with or without bevacizumab, following a similar schedule. After completing the study treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with squamous cell cancer of the head and neck that has returned or spread, excluding certain types of nasopharyngeal or skin cancer.
- No previous chemotherapy for recurrent or metastatic cancer, but may have had chemotherapy as part of initial treatment.
- At least 4 months since last chemotherapy or radiation treatment, with no disease progression during that time.
- No prior treatment with bevacizumab.
- Good overall health with an ECOG performance status of 0 or 1.
- Measurable disease based on specific criteria.
- Adequate blood cell counts and organ function as determined by specific tests.
- No known brain metastases.
- No history of severe bleeding or blood clotting disorders.
- Not currently taking certain medications that affect blood clotting.
- Women must not be pregnant or breastfeeding and must agree to use birth control during the study.
- No history of severe allergic reactions to study drugs.
- No major surgery or serious heart conditions within the past 6 months.
- No active infections or other serious medical conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Hospital | 36608 | Mobile | Alabama |
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| John L McClellan Memorial Veterans Hospital | 72205 | Little Rock | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
| Kaiser Permanente-Bellflower | 90706 | Bellflower | California |
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