Clinical trial NCT00088907 (phase 3, status: terminated)
Conditions: recurrent head and neck cancer, metastatic head and neck cancer
ICD codes: C67.5, C76.0, C44.40, D23.4, C44.49, C47.0, C49.0, C67.5, C76.0, C44.40, D23.4, C44.49, C47.0, C49.0
Drugs: docetaxel, gefitinib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1
Reason stopped: 
    it was unlikely that the primary endpoint would be reached based on the fifth interim analysis
    results.
  
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