Status:
COMPLETED
Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells. PURPOSE: This phase I t...
Detailed Description
OBJECTIVES: Primary * Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III, IVA, or IVB squamous cell carcinoma of the head and n...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Stage III, IVA, or IVB
- Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks
- Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose
- No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:
- Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy)
- Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring
- Tumor tissue samples available for EGFRvIII mutation analysis
- No known brain metastasis
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- ALT/AST \< 2 times upper limit of normal (ULN)
- Bilirubin \< ULN (unless due to Gilbert's syndrome)
- Renal
- Creatinine \< 1.5 times ULN
- Cardiovascular
- No myocardial infarction within the past year
- No cardiac ventricular arrhythmias requiring medication
- No history of cardiac disease
- No uncontrolled high blood pressure
- No unstable angina
- No congestive heart failure
- Ophthalmic
- No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca
- No severe exposure keratopathy
- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- No disorder that might increase the risk for epithelium-related complication (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No ocular inflammation or infection
- Gastrointestinal
- Able to take oral medication
- No gastrointestinal (GI) tract disease requiring IV alimentation
- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- No active peptic ulcer disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious active infection
- No other serious underlying medical condition that would preclude study participation
- No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib
- No other malignancy with the past 5 years except adequately treated non-melanoma skin cancer (unless in the same area treated with radical radiotherapy) or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- Surgery
- See Disease Characteristics
- No prior surgical procedure affecting absorption
- No concurrent ophthalmic surgery
- Other
- More than 4 weeks since other prior investigational drugs
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance with respect to INR
- Concurrent nasogastric or gastrostomy tube feeding for dysphagia allowed provided there is no evidence of significant residual mucositis (i.e., \> grade 1)
Exclusion
Key Trial Info
Start Date :
March 2 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00079053
Start Date
March 2 2004
End Date
January 18 2011
Last Update
August 4 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
London Regional Cancer Program
London, Canada, N6A 4L6
2
CHUM - Hopital Notre-Dame
Montreal, Canada, H2L 4M1