Chemotherapy + Bevacizumab for Head and Neck Cancers

Recruiting at875 trial locations

Overseen by Athanassios (Ethan) Argiris

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies chemotherapy to see how well it works with or without bevacizumab in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck squamous cell carcinoma.

Research Team

Athanassios (Ethan) Argiris

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma who haven't had chemotherapy or targeted therapy for the recurrence. They must have adequate blood counts, organ function, no severe bleeding history, controlled blood pressure without major surgery recently, and no brain metastases. Pregnant women are excluded.

Inclusion Criteria

Patients must not be receiving any other investigational agent while on the study

My cancer can be measured by scans.

Patients must meet specified laboratory values for ANC, Hgb, platelet count, creatinine clearance, total bilirubin, AST or ALT, alkaline phosphatase, and urine dipstick

Exclusion Criteria

My cancer has not caused major bleeding or required blood-thinning medication.

I have no severe allergies to docetaxel or polysorbate 80.

Women must not be pregnant or breastfeeding; agreement to use adequate birth control is required for women of child-bearing potential and men

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Carboplatin (Alkylating agents)
• Cisplatin (Alkylating agents)
• Docetaxel (Taxanes)
• Fluorouracil (Antimetabolites)

Trial Overview The study compares the effectiveness of standard chemotherapy drugs (docetaxel, cisplatin, carboplatin, fluorouracil) alone versus combined with bevacizumab (a drug that may block tumor blood supply). It's a phase III trial to see if adding bevacizumab improves treatment outcomes.

Participant Groups

Group I: Arm IVB (carboplatin, fluorouracil, bevacizumab) Experimental Treatment 4 Interventions

Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Group II: Arm IIIB (cisplatin, fluorouracil, bevacizumab) Experimental Treatment 4 Interventions

Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

Group III: Arm IIB (docetaxel, carboplatin, bevacizumab) Experimental Treatment 4 Interventions

Patients receive bevacizumab as in Arm IB and docetaxel and carboplatin as in Arm IIA.

Group IV: Arm IB (docetaxel, cisplatin, bevacizumab) Experimental Treatment 4 Interventions

Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

Group V: Arm IIIA (cisplatin, fluorouracil) Active Control 3 Interventions

Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group VI: Arm IVA (carboplatin, fluorouracil) Active Control 3 Interventions

Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group VII: Arm IIA (docetaxel, carboplatin) Active Control 3 Interventions

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group VIII: Arm IA (docetaxel, cisplatin) Active Control 3 Interventions

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School