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Alkylating agents
Chemotherapy + Bevacizumab for Head and Neck Cancers
Phase 3
Waitlist Available
Led By Athanassios (Ethan) Argiris
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST); specific criteria for previously irradiated sites
Patients must have recovered to grade 1 or better from any acute effects of prior surgery, chemotherapy, or radiation therapy, and should be > 4 weeks post-surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm b were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
Awards & highlights
Study Summary
This trial is testing chemotherapy with or without bevacizumab to see how well it works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other parts of the body.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Chemotherapy can cause nausea, fatigue, hair loss and increased infection risk. Bevacizumab might add risks like high blood pressure, bleeding problems or serious reactions related to blocking blood vessels in tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured by scans.
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I have recovered from previous cancer treatments and it's been over 4 weeks since my last surgery.
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I do not have cancer that has spread to my brain.
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I finished my chemotherapy or chemoradiotherapy 4 months ago and haven't had cancer progression since.
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I've had only one radiotherapy for my head or neck cancer.
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I am fully active or can carry out light work.
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My cancer is a type of squamous cell cancer in the head or neck, not from the skin or nasopharynx.
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My head or neck cancer has returned, cannot be cured with surgery or radiation, or has spread.
Select...
I haven't had chemotherapy or targeted therapy for my recurring or spreading head/neck cancer.
Select...
My cancer progressed after 2 rounds of initial chemotherapy.
Select...
I have never been treated with bevacizumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm b were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm b were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Overall Response Rate
Progression-free Survival (PFS)
Other outcome measures
To Collect Blood Samples Before and After Therapy for Future Correlative Studies
To Collect Tumor Tissue Samples Available at Baseline From Prior Diagnostic Procedures for Future Correlative Studies
Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Arm IVB (carboplatin, fluorouracil, bevacizumab)Experimental Treatment4 Interventions
Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
Group II: Arm IIIB (cisplatin, fluorouracil, bevacizumab)Experimental Treatment4 Interventions
Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.
Group III: Arm IIB (docetaxel, carboplatin, bevacizumab)Experimental Treatment4 Interventions
Patients receive bevacizumab as in Arm IB and docetaxel and carboplatin as in Arm IIA.
Group IV: Arm IB (docetaxel, cisplatin, bevacizumab)Experimental Treatment4 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 Control3 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 Control3 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 Control3 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 Control3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Docetaxel
1995
Completed Phase 4
~5620
Fluorouracil
2014
Completed Phase 3
~11540
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,750 Total Patients Enrolled
3 Trials studying Lip and Oral Cavity Squamous Cell Carcinoma
359 Patients Enrolled for Lip and Oral Cavity Squamous Cell Carcinoma
Athanassios (Ethan) ArgirisPrincipal InvestigatorECOG-ACRIN Cancer Research Group
2 Previous Clinical Trials
228 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not caused major bleeding or required blood-thinning medication.My cancer can be measured by scans.I have no severe allergies to docetaxel or polysorbate 80.I have recovered from previous cancer treatments and it's been over 4 weeks since my last surgery.I do not have cancer that has spread to my brain.I am not HIV-positive or not on anti-retroviral therapy.My cancer is a type of squamous cell cancer in the head or neck, not from the skin or nasopharynx.My head or neck cancer has returned, cannot be cured with surgery or radiation, or has spread.I haven't had chemotherapy or targeted therapy for my recurring or spreading head/neck cancer.My cancer progressed after 2 rounds of initial chemotherapy.I had skin cancer or cervical cancer but was treated for it, or I've been free from any other cancer for 3 years.I do not have severe numbness or pain in my hands or feet.I haven't had major heart, stroke, or serious infection issues in the past 6 months.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.I've had one round of initial cancer treatment but no chemotherapy for recurrent or metastatic disease.I finished my chemotherapy or chemoradiotherapy 4 months ago and haven't had cancer progression since.I've had only one radiotherapy for my head or neck cancer.I am fully active or can carry out light work.I have never been treated with bevacizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Arm IIIA (cisplatin, fluorouracil)
- Group 2: Arm IIIB (cisplatin, fluorouracil, bevacizumab)
- Group 3: Arm IIB (docetaxel, carboplatin, bevacizumab)
- Group 4: Arm IB (docetaxel, cisplatin, bevacizumab)
- Group 5: Arm IVA (carboplatin, fluorouracil)
- Group 6: Arm IVB (carboplatin, fluorouracil, bevacizumab)
- Group 7: Arm IIA (docetaxel, carboplatin)
- Group 8: Arm IA (docetaxel, cisplatin)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are allowed to be in this clinical trial at one time?
"Presently, this study is not looking for new patients to enroll. However, it's important to note that this study was originally posted on 8/8/2008 and was most recently edited on 9/23/2022. If you are interested in other studies, there are 3914 trials for patients with carcinoma and 1924 trials for Bevacizumab that are currently looking for participants."
Answered by AI
What illnesses or medical conditions does Bevacizumab typically alleviate?
"Bevacizumab can be used as an intervention for recurrent cervical cancer, initial treatment, and metastatic bladder cancer."
Answered by AI
Does Bevacizumab increase the risk of adverse health events?
"There is some data to support the efficacy of Bevacizumab, and as this is a Phase 3 trial, there is also multiple rounds of data to support its safety--our team gives it a 3."
Answered by AI
Could you please provide a summary of all other research done on Bevacizumab?
"City of Hope Comprehensive Cancer Center initiated research on bevacizumab in 1997. In the two and a half decades since, there have been a total of 3913 completed studies with 1924 ongoing studies. Many of these active trials are based in Chicago, Illinois."
Answered by AI
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