Trial Information

Docetaxel And Infliximab/Placebo In Non-Small Cell Lung Cancer (NSCLC) Patients Greater Than Or Equal To 65 Years Of Age Or In NSCLC Patients With Poor Performance Status: A Double-Blind Randomized, Placebo-Controlled Trial To Prevent And Treat Wasting, Anorexia, And Asthenia In Chemotherapy-Naive And Previously-Treated Patients

OBJECTIVES:

- Compare the improvement or stabilization of weight in elderly or poor performance
status patients with unresectable non-small cell lung cancer treated with docetaxel
with or without infliximab (infliximab treatment discontinued effective 10/05/05).

- Compare appetite and functional status in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the augmentation or maintenance of lean tissue in patients treated with these
regimens.

- Compare the response rates and time to disease progression in patients treated with
these regimens.

- Compare the survival of patients treated with these regimens.

- Determine whether the tumor necrosis factor-alpha polymorphisms in the -308 and -238
regions predict which cancer patients will experience loss of appetite and weight and
which patients might potentially benefit from infliximab (infliximab treatment
discontinued effective 10/05/05).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to weight loss within the past 6 months (0% vs more than 0% to less
than 5% vs at least 5%), number of prior chemotherapy regimens (0 vs 1 vs more than 1),
gender, and GBU prognostic index (good vs bad vs unsure).

- Part A (non-randomized, single-center portion of study): Five patients receive
infliximab IV (infliximab treatment discontinued effective 10/05/05) over 2 hours once
weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all
subsequent courses and docetaxel IV over 1 hour (immediately after completion of
infliximab infusion [infliximab treatment discontinued effective 10/05/05]) once weekly
on weeks 1-6 of each course. Treatment repeats every 8 weeks for 2-3 courses in the
absence of disease progression or unacceptable toxicity.

If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to
infliximab (infliximab treatment discontinued effective 10/05/05), additional patients are
accrued for part B of the study.

- Part B (randomized, multicenter portion of study): Patients are randomized to 1 of 2
treatment arms.

- Arm I (infliximab treatment discontinued effective 10/05/05): Patients receive
infliximab and docetaxel as in part A.

- Arm II: Patients receive docetaxel as in part A and placebo IV over 2 hours
according to the infliximab schedule in part A (infliximab treatment discontinued
effective 10/05/05).

Treatment in both arms repeats as in part A.

Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline,
weekly on weeks 1-8, and then monthly for the remainder of study treatment.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this
study within 3 years.