Head and Neck Cancer Clinical Trial
Official title:
A Phase I/II Study Of OSI-774 In Combination With Cisplatin In Patients With Recurrent Or Metastatic Squamous Cell Cancer Of The Head And Neck
Verified date | October 2018 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor
cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop
tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may
kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in
treating patients who have recurrent or metastatic head and neck cancer.
Status | Completed |
Enrollment | 51 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck - All primary sites, including oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus - Recurrent, unresectable, and/or metastatic disease - At least 1 measurable lesion - At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan - Lesions accessible for biopsy - Tumor specimen available for evaluation of epidermal growth factor receptor (EGFR) expression - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal: - No gastrointestinal tract disease resulting in malabsorption - No requirement for IV alimentation - No active peptic ulcer disease - Inability to swallow tablets or silicon-based G-tubes allowed Ophthalmic: - No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjogren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except carcinoma in situ of the cervix, nonmelanoma skin cancer, or second primary squamous cell cancer originating from the head and neck - No grade 2 or greater residual ototoxicity or neuropathy from prior platinum-based therapy - No significant traumatic injury within the past 21 days - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for recurrent or metastatic disease - Prior platinum-based chemotherapy with radiotherapy or platinum-based induction chemotherapy allowed - At least 6 months since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Chemotherapy - At least 4 weeks since prior radiotherapy (except low-dose, limited-fraction palliative non-myelosuppressive radiotherapy [e.g., involving less than 20% of functioning bone marrow using 800 cGy in 1 fraction or 2,000 cGy in 5 fractions]) and recovered - No prior radiotherapy to target lesion unless there is evidence of disease progression Surgery: - See Disease Characteristics - At least 21 days since prior major surgery - No prior surgical procedure affecting gastrointestinal absorption Other: - No prior EGFR-targeting therapies - No prior investigational agents for recurrent or metastatic disease - No concurrent combination anti-retroviral therapy for HIV infection - No other concurrent investigational agents - No other concurrent anticancer treatment |
Country | Name | City | State |
---|---|---|---|
Canada | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario |
Canada | Queen's University | Kingston | Ontario |
Canada | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario |
Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | Ottawa Regional Cancer Centre | Ottawa | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | National Cancer Institute (NCI) |
Canada,
Agulnik M, da Cunha Santos G, Hedley D, Nicklee T, Dos Reis PP, Ho J, Pond GR, Chen H, Chen S, Shyr Y, Winquist E, Soulieres D, Chen EX, Squire JA, Marrano P, Kamel-Reid S, Dancey J, Siu LL, Tsao MS. Predictive and pharmacodynamic biomarker studies in tum — View Citation
Siu LL, Chen X, Tsao M: A phase I/II study of erlotinib (Tarceva) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (HNSCC). [Abstract] Clin Cancer Res 9 (16): A-A92, 2003.
Siu LL, Soulieres D, Chen EX, Pond GR, Chin SF, Francis P, Harvey L, Klein M, Zhang W, Dancey J, Eisenhauer EA, Winquist E; Princess Margaret Hospital Phase II Consortium; National Cancer Institute of Canada Clinical Trials Group Study. Phase I/II trial o — View Citation
Winquist E, Soulieres D, Chen E, et al.: A phase II study of erlotinib in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (PHL002es/NCIC CTG IND.157). [Abstract] Eur J Cancer 2 (Suppl 8): A-408
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