Status:
COMPLETED
Erlotinib in Treating Patients With Metastatic and/or Recurrent Head and Neck Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the relationship between response rate and number of CA repeats in intron 1 of the epidermal growth factor receptor (EGFR) in patients with metastatic and/or locally ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00281866
Start Date
July 1 2005
End Date
March 1 2007
Last Update
October 12 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
2
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041