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IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma

A Phase 2 Trial to Evaluate ZD1839 (IRESSA) in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma (Unresectable &Inoperable)

NCT00242749•AstraZeneca

View on ClinicalTrials.gov

Summary

· To evaluate the disease free survival rate at 2 years of patients with advanced head and neck carcinoma treated with ZD1839 250 mg administered once daily in combination with cisplatin and a standard course of radiotherapy.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed squamous head and neck carcinoma
•2. Extra-laryngeal tumour or laryngeal tumour that is inoperable (not resectable) considered by Head and Neck Cancer Committee
•3. Stage III-IV (IVa and IVb) disease
•4. Measurable disease according to RECIST criteria
•5. Aged 18 years or older
•6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
•7. Normal renal, haematological (neutrophils \>1´5 x 109/ L and platelets \> 100 x 109/L) and liver function

Exclusion Criteria

•1\. Previous treatment for initial disease (neck dissection in N3 is allowed) 2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 3. Incomplete healing from previous oncologic or other surgery 4. Absolute neutrophil count (ANC) less than 1.5 x 109/ L, or platelets less than 100x 109/L 5. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR) 6. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 7. Serum creatinine greater than 1.25 times the ULRR 8. ALT or AST greater than 2.5 times the ULRR 9. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial 10. Active dermatoses (e.g. psoriasis, eczema) 11. Corneal abnormalities (other than scars, congenital abnormality or corneal tear film), history of dry eye syndrome or ocular surface diseases and neurological disorders 12. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin or drugs with known corneal toxicity 13. Pregnancy or breastfeeding (women of child-bearing potential) 14. Patient incapacity to reliably follow the treatment or follow up for family, economic or geographical reasons.

Locations (4)

Research Site

Badalona, Spain

Research Site

Málaga, Spain

Research Site

Murcia, Spain

Research Site

Santander, Spain

Key Dates

Start Date

December 1, 2002

Completion Date

July 1, 2007

Last Updated

April 23, 2009

Enrollment

Estimated participants

Conditions

Cancer of Head and Neck

Interventions

Gefitinib, Cisplatin and Radiotherapy

DRUG

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

NCT02296684

Cancer of Head and NeckHead and Neck Cancer+4 more

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COMPLETEDNA

RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma

Inclusion Criteria

Exclusion Criteria

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