ZD1839 (NSC #715055, IND #61187) With Induction Paclitaxel And Carboplatin Followed By Either Radiation Or Concomitant Radiation With Weekly Paclitaxel And Carboplatin In Stage III Non-Small Cell Lung Cancer, A Phase II Study
PRIMARY OBJECTIVES:
I. To determine whether ZD1839 (gefitinib) at 250 mg orally every day administered
concomitantly with radiotherapy after induction treatment consisting of paclitaxel,
carboplatin, and ZD1839 among patients with inoperable stage III non-small cell lung cancer
and Common Terminology Criteria (CTC) performance status 2 or poor risk performance status
0-1 is tolerable.
II. To determine whether ZD1839 at 250 mg orally every day administered concomitantly with
paclitaxel, carboplatin, and radiation after induction treatment consisting of paclitaxel,
carboplatin, and ZD1839 among patients with inoperable stage III non-small cell lung cancer
and CTC performance status 0-1 is tolerable.
III. To determine the overall response rate, failure-free survival, and survival after
treatment with induction chemotherapy with daily ZD1839, concomitant radiotherapy and daily
ZD1839, and post-radiotherapy single agent daily ZD1839 among patients with CTC performance
status 2 or poor risk performance status 0-1 and inoperable stage III non-small cell lung
cancer.
IV. To determine the overall response rate, failure-free survival, and survival after
treatment with induction chemotherapy and daily ZD1839, concomitant chemoradiotherapy and
daily ZD1839, and post-radiotherapy single agent daily ZD1839 among patients with CTC
performance status 0-1 and inoperable stage III non-small cell lung cancer.
V. To determine if elevated circulating epidermal growth factor receptor (EGFR) levels prior
to treatment, as determined by either quantitative polymerase chain reaction (PCR) or direct
enzyme-linked immunosorbent assay (ELISA) measurement, may predict for response to therapy
with EGFR inhibitors.
OUTLINE:
All patients receive induction therapy comprising paclitaxel IV over 3 hours followed by
carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Patients then receive therapy based on their assigned stratum.
STRATUM I: Patients receive gefitinib orally (PO) daily for 7 weeks. Patients also undergo
concurrent radiotherapy once daily 5 days a week for 7 weeks.
STRATUM II: Patients receive gefitinib and radiotherapy as in stratum I concurrently with
paclitaxel IV over 1 hour followed by carboplatin over 30 minutes once weekly for 7 weeks.
Patients then receive gefitinib PO daily in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months for 2 years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival (Stratum I)
Kaplan-Meier curves will be used to describe overall survival in each stratum.
From randomization until death or last known follow-up, assessed up to 10 months
No
Neal Ready
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-02821
NCT00040794
May 2002
Name | Location |
---|---|
Cancer and Leukemia Group B | Chicago, Illinois 60606 |