Trial information
A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship between Skin Toxicity and Survival
Status: Recruiting
Protocol number: ML20296
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of Tarceva in combination with gemcitabine in unresectable and/or metastatic cancer of the pancreas : relationship between skin rash and survival
Brief summary: This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 151.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pancreatic Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Relationship between grade 2 Tarceva-related skin rash and >=6 months survival Time frame: Event driven
Key secondary outcomes: 1. PFS, 6 month survival, time to treatment failure, objective response rate, duration of response. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- locally advanced and/or metastatic pancreatic cancer (stage III or IV);
- Karnofsky performance Status of >=60%.
Exclusion criteria:
- local(stage IA to IIB) pancreatic cancer;
- <=6 months since last adjuvant chemotherapy;
- previous systemic therapy for metastatic pancreatic cancer;
- other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
- clinically significant cardiovascular disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2007
Trial registration date: 04/17/2007
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Spain
- Alcorcon
- Alcoy
- Barcelona
- Córdoba
- El Palmar Murcia
- Elche
- Girona
- Granada
- Guadalajara
- Jaen
- La Coruna
- Lleida
- Lugo
- Madrid
- Manresa
- Murcia
- Navarra
- Palma de Mallorca
- Pontevedra
- Sabadell
- Sagunto
- Santander
- Sevilla
- Valencia
- Zaragoza
