Trial information

A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Status: Recruiting

Protocol number: BO21128

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, open-label, dose-escalation to rash study to assess the effect of Tarceva in combination with gemcitabine on overall survival in patients with metastatic pancreatic cancer.

Brief summary: This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 400.

Study phase: II

Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study

Condition: Pancreatic Cancer

Intervention type: Drug

Intervention name: erlotinib [Tarceva]

Primary outcome: 1. Overall survival Time frame: Event driven

Key secondary outcomes: 1. Progression free survival; response and disease control rates according to RECIST Time frame: Event driven 2. Adverse events, lab parameters Time frame: Throughout study

Inclusion criteria:

• adult patients, >=18 years of age;
• histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease;
• ECOG performance status of 0-1.

Exclusion criteria:

• local, or locally advanced, pancreatic cancer;
• prior systemic treatment for metastatic pancreatic cancer;
• <=6 months since last adjuvant chemotherapy;
• other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Trial registration date: 04/01/2008

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Argentina

• Buenos Aires
• Rosario
• Santa Fe

Australia

• Adelaide
• Ballarat
• Brisbane
• Canberra
• Frankston
• Liverpool
• St. Leonards
• Sydney

Austria

• Salzburg
• Wien

Belgium

• Antwerpen
• Bruxelles
• Gent
• Leuven
• Liege

Brazil

• Belo Horizonte
• Ijuí
• Salvador
• Santo Andre
• Sao Paulo

Canada

• Mississauga, ON
• Toronto, ON

China

• Hong Kong

Croatia

• Zagreb

Denmark

• Copenhagen Oe (Ø)
• Herlev
• Hillerød

France

• Angers
• Besancon
• Brest
• Paris
• Saint Priest En Jarez

Germany

• Berlin
• Bochum
• Bonn
• Esslingen
• Halle
• Hamburg
• Hamm
• Kaiserslautern
• Leipzig
• Marburg
• Münchengladbach
• Saarbruecken
• Trier
• Ulm

Greece

• Heraklion
• Thessaloniki

Israel

• Haifa
• Jerusalem
• Petah Tikva
• Tel Aviv
• Zerifin

Italy

• Chieti
• Firenze
• Napoli
• Orbassano
• Pordenone
• San Giovanni Rotondo
• Udine

Lithuania

• Vilnius
• Vilnius Lt

Mexico

• Mexico City

Poland

• Gliwice
• Lublin
• Poznan
• Warszawa

Romania

• Cluj-Napoca
• Sibiu

Serbia and Montenegro

• Belgrade
• Sremska Kamnica

Singapore

• Singapore

Spain

• Girona
• Madrid

Taiwan

• Taipei

United Kingdom

• London
• Southampton