Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT00079053 | Completed Phase 1 DMC

• 4 other identifiers: HN5CAN-NCIC-HN5ROCHE-CAN-NCIC-HN5CDR0000353485
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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 trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma (cancer) of the head and neck.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; salivary gland squamous cell carcinoma; stage III salivary gland cancer; stage IV salivary gland cancer

Outcome Measures

Primary Outcomes (2)

• Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1

• Recommended phase II dose at the end of course 1

Secondary Outcomes (2)

• Correlative studies (archival and prospective) at accrual completion

• Disease-free survival

Interventions

erlotinib hydrochloride DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• Roche Pharma AG: collaborator

Study Sites (2)

London Regional Cancer Program

London, N6A 4L6, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms

Interventions

Erlotinib Hydrochloride; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Denis Soulieres, MD, MSC

  CHUM - Hotel Dieu Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: March 2, 2004
• Primary Completion: December 9, 2008
• Study Completion: January 18, 2011
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)