Clinical trial · Interventional
Erlotinib in Treating Patients With Metastatic and/or Recurrent Head and Neck Cancer
Genotypic-Based Pharmacodynamic Evaluation of Erlotinib (Erlotinib (Tarceva™, OSI Pharmaceuticals, Uniondale, NY) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Relationship between response rate and number of CA repeats in intron 1 of the EGFR
Secondary outcomes (5)
- measure
- Time to disease progression
- measure
- Survival
- measure
- Toxicity
- measure
- Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples
- measure
- Relationship between erlotinib hydrochloride exposure and outcome, toxicity, and pharmacodynamic effects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available