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Anti-cancer agent
Chemotherapy + Erlotinib for Head and Neck Cancer
Phase 2
Recruiting
Led By Xiuning Le, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG PS ≤ 2 (Appendix C)
Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days after third cycle of treatment
Awards & highlights
Study Summary
This trial is studying if adding erlotinib to standard chemotherapy can help control SCCHN and to see if it is safe.
Who is the study for?
Adults over 18 with a specific type of throat cancer (SCCHN) that can be surgically removed may join this study. They must have normal organ function and blood counts, not be on other cancer treatments, and agree to use birth control if they can have children. People with serious health issues, different cancers within the last two years, or allergies to similar drugs cannot participate.Check my eligibility
What is being tested?
The trial is testing whether adding Erlotinib to standard chemo (Docetaxel plus Cisplatin or Carboplatin) before surgery helps treat throat cancer better than chemo alone. Some patients will get Erlotinib while others will get a placebo (a fake drug), chosen randomly.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion, fatigue, digestive problems like nausea and diarrhea from chemotherapy; Erlotinib might cause rashes and breathing difficulties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days after third cycle of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days after third cycle of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological Complete Response (pCR)
Side effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
Trial Design
2Treatment groups
Experimental Treatment
Group I: Chemotherapy + PlaceboExperimental Treatment5 Interventions
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Group II: Chemotherapy + ErlotinibExperimental Treatment5 Interventions
Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Phone Call
2016
Completed Phase 4
~20190
Docetaxel
1995
Completed Phase 4
~5620
Erlotinib
2011
Completed Phase 4
~2290
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,211 Total Patients Enrolled
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,109 Total Patients Enrolled
The Kadoorie Charitable FoundationsOTHER
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatments for a different head and neck cancer before, but not for my current one.I don't have severe gut issues that could affect medication absorption, but I may use a feeding tube.My doctor believes my cancer can be removed with surgery.I am allergic to certain chemotherapy drugs or their ingredients.I am not on any cancer treatment except for hormone therapy for breast or prostate cancer.I have or might have stage III, IVA, or IVB oral cavity cancer.I am 18 years old or older.I can use birth control during and for 30 days after the study, and I can provide a negative pregnancy test before starting treatment.I can take care of myself and perform daily activities.I haven't had any other cancers except for some skin, cervical, or breast cancers in the last 2 years.My cancer is not squamous cell carcinoma.I am not pregnant, breastfeeding, and I use effective birth control.My cancer did not start in my mouth.My liver, kidneys, and bone marrow are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy + Placebo
- Group 2: Chemotherapy + Erlotinib
Awards:
This trial has 0 awards, including: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.
What precedent exists for the use of Chemotherapy in clinical experiments?
"Presently, 365 clinical trials concerning Chemotherapy are ongoing with 132 in the third phase. While most of these studies take place in Fuzhou, Fujian; a total of 27,858 locations across the world are hosting such investigations."
Answered by AI
What risks might come with utilizing Chemotherapy treatments?
"As this trial is only in its second phase, with evidence of safety but not efficacy, the team at Power gauged chemotherapy's risk level as a 2 on their 1-3 scale."
Answered by AI
What maladies can be treated with Chemotherapy?
"Chemotherapy is commonly administered as a treatment for soft tissue sarcoma (STS) and has been used to aid with conditions such as neoplasm metastasis, BRCA1 gene mutation, and those who have not previously undergone any treatments."
Answered by AI
Are there still openings in this research endeavor for participants?
"As evidenced on clinicaltrials.gov, this investigation is not currently recruiting participants. Initially posted in December 2013 and most recently revised in September 2022, no fresh candidates are being accepted at present time despite the 3369 other studies seeking recruits."
Answered by AI
What is the maximum number of participants being accepted for this clinical experiment?
"This research endeavour has concluded its recruitment for participants. It was initially announced on December 16th 2013 and final edits were made on September 22nd 2022. If you are searching for other clinical trials, there are currently 3004 studies involving carcinoma that require subjects as well as 365 chemotherapy experiments with open enrollment slots."
Answered by AI
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