Head and Neck Cancer Clinical Trial
Official title:
Genotypic-Based Pharmacodynamic Evaluation of Erlotinib (Erlotinib (Tarceva™, OSI Pharmaceuticals, Uniondale, NY) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
recurrent and/or metastatic head and neck cancer.
Status | Completed |
Enrollment | 37 |
Est. completion date | March 2007 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck - Metastatic and/or locally recurrent disease - No undifferentiated and nonkeratinizing carcinomas, including lymphoepitheliomas of all locations, as well as tumors of the parotid gland - WHO Type I squamous cell carcinoma of the nasopharynx are allowed - Incurable with surgery or radiotherapy - Measurable disease, defined as = 1 target lesion = 20 mm OR = 10 mm on spiral CT scan - If the only site of measurable disease is in a previously irradiated area, the patient must have documented progressive disease by tomography or biopsy-proven residual carcinoma - No symptomatic brain metastases that are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life-threatening, or have required radiotherapy within the last 14 days PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Predicted life expectancy = 12 weeks - Absolute neutrophil count = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Bilirubin = 1.5 times upper limit of normal (ULN) - AST and/or ALT = 2.5 times ULN - Creatinine = 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must practice effective contraceptive measures - No other prior malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer - No active or uncontrolled infection or other serious illnesses or medical conditions - No history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No more than two prior chemotherapy regimens for locally recurrent and/or metastatic disease - Prior induction chemotherapy or chemoradiotherapy with curative intent for local disease allowed provided patient has received no more than two prior chemotherapy regimens for recurrent disease - Prior therapy must have been completed a minimum of 14 days prior to study AND patient has recovered - No prior molecular-directed therapies, such as tyrosine kinase inhibitors and/or monoclonal antibodies - At least 14 days must have elapsed between the end of radiotherapy and study registration and recovered - At least 14 days since prior surgery AND wound healing has occurred - At least 7 days since prior herbal extracts and tinctures with CYP3A inhibitory activity, including any of the following: - Hydrastis canadensis (goldenseal) - Uncaria tomentosa (cat's claw) - Echinacea angustifolia roots - Trifolium pratense (wild cherry) - Matricaria chamomilla (chamomile) - Glycyrrhiza glabra (licorice) - Dillapiol - Naringenin - No other concurrent anticancer therapy or other investigational agents - No concurrent administration of any of the following: - Phenytoin - Carbamazepine - Rifampicin - Barbiturates - Hypericum perforatum (St. John's wort) - CYP3A inhibitors (e.g., itraconazole) |
Allocation: Non-Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario 12 de Octubre | Madrid | |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relationship between response rate and number of CA repeats in intron 1 of the EGFR | No | ||
Secondary | Time to disease progression | No | ||
Secondary | Survival | No | ||
Secondary | Toxicity | Yes | ||
Secondary | Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples | No | ||
Secondary | Relationship between erlotinib hydrochloride exposure and outcome, toxicity, and pharmacodynamic effects | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |