SWOG clinical trial number
S0322

Single Agent ZD-1839 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), Pharmacology.

Closed
Phase
Accrual
25%
Abbreviated Title
ZD1839/75 yrs or older and in a cohort of 50 yrs or older/Adv. H&N NSCLC
Activated
08/15/2003
Closed
02/15/2005
Participants
Limited: Institutions Listed on the Title Page

Research committees

Early Therapeutics & Rare Cancers
Head and Neck Cancer
Lung Cancer

Treatment

ZD1839

Eligibility Criteria Expand/Collapse

Pts must have histo or cyto conf head and neck carcinoma or non-small cell lung cancer which is metastic or unresectable. Pts must be 75 yrs or older or 50 yrs of age or younger. Pts must have serum creat = IULN; bili = IULN; SGOT/SGPT = IULN; alk phos = IULN; AGC >/= 1,500; PLT >/= 100,000. These tests must be obtained w/in 28 days prior to reg. Pts must have rec'd at least 1 but no more than 3 prior chemo regimens for their disease and must have recovered from effects. Pts must have a Zubrod PS of 0-2. Pts must agree to undergo pharmacokinetic sampling and sample submission (see Sect 15). Pts must be able to swallow oral med in pill form. Pts with brain mets are eligible if their brain mets. have been treated and if they are stable. Pts must not require agents that induce CYP3A4. Pts known to be HIV-positive and receiving anti-retroviral therapy are not eligible. Pts with any severe or uncontrolled systemic disease are not eligible. Pts must not be pregnant or nursing. Pts must not be planning on receiving concurrent rad therapy, hormone therapy, chemo, or immune therapy for malignancy.