A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer
- Determine the recommended phase II dose of AZD2171 when administered with standard
combination chemotherapy in patients with advanced non-small cell lung cancer or
- Determine the safety, tolerability, toxicity profile, dose-limiting toxicities, and
pharmacokinetic profile of this treatment regimen.
- Assess the antitumor activity of this treatment regimen in patients with measurable
- Correlate the toxicity profile with pharmacokinetics.
OUTLINE: This is a multicenter, open-label, dose-escalation study of AZD2171. Patients are
assigned to 1 of 2 treatment groups according to disease.
- Group 1 (non-small cell lung cancer): Patients receive gemcitabine hydrochloride IV on
days 1 and 8 and cisplatin IV on day 1. Patients also receive oral AZD2171 once daily
beginning on day 2. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
- Group 2 (colorectal cancer): Patients receive oxaliplatin IV over 2 hours and
leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46
hours on days 1 and 2. Patients also receive oral AZD2171 once daily beginning on day
3. Treatment repeats every 14 days in the absence of disease progression or
In both groups, cohorts of 3-6 patients receive escalating doses of AZD2171 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Gerald Batist, MD
Jewish General Hospital
United States: Federal Government