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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)

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    Page 1 of 1 (2 locations)

    1

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410

    2

    Hospital Universitario 12 de Octubre

    Madrid, Spain, 28041