Trial information
A Study of Xeloda (Capecitabine) and Herceptin (Trastuzumab) in Patients With Advanced or Metastatic Pancreatic Cancer
Status: No longer recruiting
Protocol number: ML17743
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: An open-label study of Herceptin and Xeloda on progression-free survival in treatment-naïve patients with HER2-positive advanced or metastatic pancreatic cancer
Brief summary: This study will evaluate the efficacy and safety of oral Xeloda plus intravenous Herceptin in patients with HER2-positive advanced or metastatic pancreatic cancer. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Target sample size is
37.
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: trastuzumab[Herceptin]
Primary outcome: 1. Progression-free survival rate after 3 months
Key secondary outcomes: 1. Response rate; progression-free survival and overall survival rates after 9 months; clinical benefit rate; assessments of CA 19-9 and HER2 and correlation with treatment response; quality of life; and toxicity
Inclusion criteria:
- adult patients >=18 years of age;
- advanced or metastatic pancreatic cancer;
- no prior chemotherapy or radiotherapy;
- HER2 positive; (IHC [2+] or [3+] and FISH positive);
- >=1 measurable lesion;
- no option for potentially curative surgical or radiological therapy.
Exclusion criteria:
- concurrent chemotherapy or immunotherapy;
- co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
- severe renal or hepatic dysfunction, or clinically significant cardiac or pulmonary disease;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2004
Trial registration date: 08/30/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Esslingen
- Freiburg
- Heidelberg
- Mannheim
- München
- Regensburg
- Schweinfurt
- Tübingen
- Ulm
