IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Neoplasms, Squamous Cell

Treatments: Drug: Gefitinib (Iressa); Radiation: radiotherapy; Drug: cisplatin; Drug: gefitinib (Iressa)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00229723

1839IL/0706

EudraCT number 2004-000358-21

D7919C00706

Details and patient eligibility

About

The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
• No prior surgery or chemotherapy/biological therapy/radiation therapy
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Life expectancy of more than 12 weeks

Exclusion criteria

• Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
• Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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224 participants in 7 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Radiation + cisplatin; followed by placebo as maintenance therapy

Treatment:

Radiation: radiotherapy

Drug: cisplatin

2

Experimental group

Description:

250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy

Treatment:

Radiation: radiotherapy

Drug: gefitinib (Iressa)

Drug: cisplatin

3

Experimental group

Description:

500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy

Treatment:

Radiation: radiotherapy

Drug: Gefitinib (Iressa)

Drug: cisplatin

4

Experimental group

Description:

gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy

Treatment:

Radiation: radiotherapy

Drug: gefitinib (Iressa)

Drug: cisplatin

5

Experimental group

Description:

gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy

Treatment:

Radiation: radiotherapy

Drug: Gefitinib (Iressa)

Drug: cisplatin

6

Placebo Comparator group

Description:

placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy

Treatment:

Radiation: radiotherapy

Drug: gefitinib (Iressa)

Drug: cisplatin

7

Placebo Comparator group

Description:

placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy

Treatment:

Radiation: radiotherapy

Drug: Gefitinib (Iressa)

Drug: cisplatin