Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small … (NCT00068497) | Clinical Trial Compass
CompletedNot Applicable
Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
United States40 participantsStarted 2003-08
Plain-language summary
This phase I trial is studying the side effects of gefitinib in treating patients with metastatic or unresectable head and neck cancer or non-small cell lung cancer. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer which is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective or are likely to be as effective as ZD1839; patients with known brain metastases are only eligible if their brain metastases have been treated and if in the opinion of the treating physician they are stable
* Patients must be 75 years or older, or 50 years of age or younger
* Serum creatinine =\< the institutional upper limit of normal
* Bilirubin =\< the institutional upper limit of normal
* SGOT or SGPT =\< 2.5 x the institutional upper limit of normal; SGOT and SGPT could be =\< 5 x the upper limit of normal if the patient has liver metastases as long as the bilirubin is normal
* AGC of \>= 1,500/ul
* Platelet count of \>= 100,000/ul
* Patients requiring agents that induce CYP3A4 are excluded from the study, at the present time, agents known to induce CYP3A4 include the antibiotics nafcillin and rifampin, the anticonvulsants carbamazepine, phenobarbital, phenytoin, oxcarbazepine, fosphenytoin and primidone as well as St. John's Wort, rifabutin, rifapentine and modafinil
* Patients may or may not have received prior chemotherapy; patients must not have a curative option and in the opinion of the treating physician there is no other treatment option likely to provide greater benefit; patients must not have received…
What they're measuring
1
Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting
Timeframe: 1 year
2
Peak ZD1839 concentration level
Timeframe: Up to 3 years
3
Elimination half-life
Timeframe: Up to 3 years
4
Toxicity rates between the two age groups by CTCAE version 3.0