Please assess the completion status of the following clinical trial:

Trial Title: Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck; patient must not have nasopharyngeal carcinoma of histologic types World Health Organization (WHO) 2 and 3~* Metastatic or locally recurrent carcinoma of the head and neck that is considered incurable by local therapies~* Any number of prior chemotherapy or biologic/targeted therapy regimens is allowed~* No prior systemic EGFR inhibitors, such as ZD1839 (Iressa, gefitinib)/Iressa (AstraZeneca), ABX-EBX (Abgenix), MDX-447 (Medarex/Merck), OSI-774/Tarceva (OSI pharmaceuticals), C225/Cetuximab (ImClone), PKI166 (Novartis), CI-1033 (Parke-Davis), EKB-569 (Wyeth Ayerst); treatment with paclitaxel is allowed if the patient did not progress while on paclitaxel~  * NOTE: the use of cetuximab given concurrently with radiation or chemoradiotherapy for up to 9 total weekly doses, as part of initial potentially curative therapy is allowed, if completed \> 6 months prior to registration~* Patients must not receiving any other investigational agent while on the study~* Patients must have either:~  * Strata A:~    * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 (in bed 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities; up and about more than 50% of waking hours), AND no prior chemotherapy for recurrent metastatic head and neck cancer OR~ * Strata B~    * PS 0-2 AND prior chemotherapy (i.e. one or more prior chemotherapy regimens (without docetaxel)) for locally recurrent/metastatic disease or exposure to prior chemotherapy (without docetaxel) as part of primary curative therapy \< 6 months prior to randomization; patients who receive chemotherapy as part of potentially curative therapy of primary disease within 6 months of randomization will be considered as having prior chemotherapy for recurrent/metastatic disease, whereas patients who received chemotherapy as part of potentially curative therapy of disease \> 6 months of randomization will be considered as having no prior chemotherapy for recurrent/metastatic disease~* Patients must have fully recovered from the effects of any prior surgery, chemotherapy, or radiation therapy~  * A minimum time period of 3 weeks must elapse between the completion of radiation therapy and randomization to the study~ * A minimum period of 4 weeks must elapse between the last administration of any prior chemotherapy and randomization to the study~ * At least 2 weeks must elapse between the last administration of biologic/targeted therapy and randomization to the study~ * Patients must be \> 3 weeks since major surgery, or significant traumatic injury prior to randomization~* Absolute neutrophil count (ANC) \>= 1500 /mm\^3~* Platelets \>= 100,000 /mm\^3~* Hemoglobin \>= 8.0 g/dl~* Bilirubin within normal limits~* Creatinine \< 2.0 or creatinine clearance of \> 60 ml/min~* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy~* Women of childbearing potential and sexually active males must use an accepted and effective method of contraception while on treatment and for three months after the completion of treatment~* Patients must have measurable or non-measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST); baseline measurements and evaluations must be obtained \< 4 weeks of randomization; all areas of disease should be recorded and mapped out in order to assess response and uniformity of response to therapy; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy; persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiation therapy~  * Radiographic findings are acceptable providing that clear-cut measurements can be made~* Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated. Patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 5 years post diagnosis~* Drugs that are Cytochrome P450 3A4 (CYP3A4) inhibitors should be generally avoided and if possible, discontinued, 1 week prior to initiating study drug; however, if medically necessary, they can be taken with caution after consulting with the study chair~* From patients consenting to participate in the correlative studies:~  * Tissues must be submitted as outlined in Section 10; if tissue cannot be submitted, written justification must be submitted to the ECOG Pathology Coordinating Office~Exclusion criteria:~* Prior therapy with docetaxel at any time (even if part of prior curative treatment)~* Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or serious arrhythmia requiring medication~* Hypercalcemia related to head and neck cancer~* Brain metastasis~* Current peripheral neuropathy \>= grade 2 at time of randomization~* Patients have co-existing condition that would preclude full compliance with the study~* Known hypersensitivity to ZD1839 (Iressa, gefitinib) or any excipients of this product; prior history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80~* HIV positive patient's receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with ZD1839 (Iressa, gefitinib)~* Patients have had tumor-related hemorrhagic events in the previous three months that required as major medical intervention, such as surgery or embolization~* Patients are on therapeutic anticoagulation or have tumors that are unequivocally invading major vessels (e.g. carotid artery)~* Females are pregnant or breast feeding because chemotherapy may be harmful to the fetus or the nursing infant; also, the effects of ZD1839 (Iressa, gefitinib) on the developing human fetus are unknown

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Arm I (docetaxel and placebo) (Type: ACTIVE_COMPARATOR): Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
- Arm II (docetaxel and gefitinib) (Type: EXPERIMENTAL): Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~ZD1839 (Iressa, gefitinib) will be given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy