Erlotinib in Treating Patients With Metastatic and/or Recurrent Head and Neck Cancer

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 with recurrent and/or metastatic head and neck cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

Criteria

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)