Clinical Trial Protocol Registry
A Study of Tarceva (Erlotinib) in Combination With Alimta in Patients With Non-Small Cell Lung Cancer.
- Protocol number:
- Hoffmann-La Roche Ltd
- Company division:
- Official Scientific Title:
- An open-label study to determine the maximum tolerated dose of Tarceva in combination with Alimta in patients with advanced non-small cell lung cancer
- Brief summary:
- This study will evaluate tolerability, pharmacokinetics and anti-tumor activity of combination doses of Tarceva and Alimta in patients with advanced non-small cell lung cancer. Cohorts of patients will receive Alimta at doses starting from 500mg/m2 iv up to 900mg/m2 every 21 days, in combination with Tarceva starting with 100mg escalating to 150mg. Pharmacokinetic samples will be collected, and tolerability and safety data reviewed, before dose escalation. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals. Target sample size is 20.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety study
- Non-Small Cell Lung Cancer
- Intervention type:
- Intervention name:
- erlotinib [Tarceva]
- Primary outcome:
- Maximum tolerated dose of Tarceva in combination with Alimta.
- Key secondary outcomes:
- Efficacy: best response from treatment start to treatment progression. Pharmacokinetics: AUC and Cmax of Tarceva and Alimta.
- Inclusion criteria:
- adult patients, >=18 years of age;
- locally advanced non-small cell lung cancer;
- patients who have failed first-line platinum-containing chemotherapy, or for whom combined therapy with Tarceva and Alimta is considered appropriate;
- measurable disease;
- >=4 weeks since prior surgery or radiotherapy.
- Exclusion criteria:
- prior exposure to agents directed at the HER axis, or to Alimta molecular targets;
- brain or CNS metastases;
- unstable systemic disease.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- August, 2005
- Trial registration date:
- Date last updated:
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