ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer

NCT ID: NCT00242762

Last Updated: 2011-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2006-03-31

Brief Summary

The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ZD1839 (IRESSA™)

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged 18 and 70 years, inclusive

2. Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN

3. Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx

4. At least one uni-dimensionally measurable lesion according to the RECIST

5. World Health Organisation (WHO) performance status (PS) of 0 or 1

6. No previous chemotherapy for recurrent or metastatic disease

7. Before subject registration a quality of life questionnaire should be completed

Exclusion Criteria

1. Previous chemotherapy for recurrent or metastatic disease

2. Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy

3. Known severe hypersensitivity to ZD1839 or any of the excipients of this product

4. Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80

5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

6. Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)

7. Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl

8. Serum bilirubin greater than the upper limit of the reference range (ULRR)

9. Serum creatinine greater than 1.5 mg/dl despite adequate rehydration

10. Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection

11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR

13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

14. Pregnancy or breast feeding (women of child-bearing potential)

15. Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort

16. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment

17. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Spain Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Facility

Granada, , Spain

Research Facility

Madrid, , Spain

Research Facility

Murcia, , Spain

Research Site

Seville, , Spain

Countries

Spain

Other Identifiers

1839IL/0504

Identifier Type: -

Identifier Source: org_study_id