Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Single Agent ZD-1839 (NSC-715055, IND-61187) in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger)
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
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 prior treatment with EGFR inhibitors; patients must have recovered from the effects of prior therapy; all prior therapies must be documented - Patients must have a performance status of 0-2 by Zubrod standards - Patients must not be planning to receive concurrent radiation therapy, hormone therapy, chemotherapy or immune therapy for malignancy while receiving protocol treatment - Patients must agree to undergo pharmacokinetic sampling and sample submission - Patients known to be HIV positive and receiving retroviral therapies are not eligible - Patients with any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac or infection) are not eligible - Patients must be able to swallow oral medication in pill form; patients may not receive study medication through a feeding tube - A baseline slit lamp examination is NOT required; however, patients with eye symptoms (eye pain, tearing, redness, vision problems) or known eye disorders should be evaluated by an ophthalmologist/optometrist prior to registration and the results documented on the toxicity form in the notes section - Patients must not be pregnant or nursing; patients of reproductive potential must have agreed to use an effective contraceptive method - If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day - In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding guidelines - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Southwest Oncology Group | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting | 1 year | No | |
| Primary | Peak ZD1839 concentration level | Up to 3 years | No | |
| Primary | Elimination half-life | Up to 3 years | No | |
| Primary | Toxicity rates between the two age groups by CTCAE version 3.0 | Up to 3 years | Yes | |
| Primary | Responses observed | Will be reported separately for the two tumor types, i.e., head and neck vs. lung cancer, with 95% confidence intervals for the estimated response rates. | Up to 3 years | No |
| Primary | Survival for each tumor type | Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals. | Up to 3 years | No |
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