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Phase III Randomized, Placebo Controlled, Trial Of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib, NSC 715055) In Performance Status 2 Or Previously Treated Patients With Recurrent Or Metastatic Head And Neck Cancer

Phase 3
18 Years
80 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

Phase III Randomized, Placebo Controlled, Trial Of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib, NSC 715055) In Performance Status 2 Or Previously Treated Patients With Recurrent Or Metastatic Head And Neck Cancer

Inclusion Criteria


- Histologically or cytologically confirmed squamous cell carcinoma of the head and

- Metastatic or locally recurrent disease

- No histologic type WHO 2 or 3 nasopharyngeal carcinoma

- Incurable by local therapies

- Meets 1 of the following criteria:

- ECOG 2 AND no prior chemotherapy for metastatic or locally recurrent head and neck

- ECOG 0-2 AND received prior chemotherapy (i.e., ≥ 1 prior chemotherapy regimen
[without docetaxel]) for metastatic or locally recurrent disease OR received prior
chemotherapy (without docetaxel) as part of a primary curative therapy within the
past 6 months

- Measurable or non-measurable disease

- Disease within a previously irradiated field is considered measurable provided there
is unequivocal disease progression or biopsy-proven residual carcinoma after

- Persistent disease after radiotherapy must be biopsy-proven ≥ 8 weeks after
completion of radiotherapy

- No tumors that are unequivocally invading major vessels (e.g. carotid artery)

- No tumor-related hemorrhagic events in the past 3 months that require major medical
intervention (e.g., surgery or embolization)

- No known brain metastasis



- 18 and over

Performance status

- See Disease Characteristics

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL


- Alkaline phosphatase AND AST or ALT meeting criteria for 1 of the following:

- Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times UNL AND AST or ALT ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 5 times ULN and AST or ALT normal

- Bilirubin normal

- Renal

- Creatinine < 2.0 mg/dL OR

- Creatinine clearance > 60 mL/min


- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure

- No serious arrhythmia requiring medication


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

- No hypercalcemia related to head and neck cancer

- No peripheral neuropathy ≥ grade 2

- No hypersensitivity to gefitinib or any of its excipients

- No severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

- No unstable systemic disease

- No active infection

- No significant traumatic injury within the past 3 weeks

- No other malignancy within the past 5 years except curatively treated squamous cell
or basal cell skin cancer or carcinoma in situ of the cervix

- No other co-existing condition that would preclude study compliance


Biologic therapy

- No prior monoclonal antibody ABX-EBX or monoclonal antibody MDX-447

- No prior cetuximab

- At least 2 weeks since prior biologic/targeted therapy

- No concurrent immunotherapy

- No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim


- See Disease Characteristics

- Prior paclitaxel allowed provided there was no disease progression during treatment

- At least 4 weeks since prior chemotherapy and recovered

- No prior docetaxel

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent antitumor hormonal therapy

- Concurrent contraceptives, replacement steroids, and dexamethasone allowed


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy


- At least 3 weeks since prior major surgery and recovered


- See Disease Characteristics

- No other prior systemic epidermal growth factor receptor inhibitors, including any of
the following:

- Gefitinib

- Erlotinib

- PKI166

- CI-1033

- EKB-569

- No concurrent CYP3A4 inducers, including any of the following:

- Phenytoin

- Carbamazepine

- Rifampin

- Phenobarbital

- Hypericum perforatum (St. John's wort)

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent proton pump inhibitors or H2 antagonists within 4 hours after gefitinib

- No concurrent therapeutic anticoagulation

- No other concurrent antitumor therapy

- No other concurrent experimental medications

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms



University of Medicine and Dentistry of New Jersey Newark, New Jersey  07103-2425