Palliative Chemotherapy (2nd line) with Imatinib (Glivec™) in Patients with Bile Duct Cancer

Completed

• Conditions: on-resectable bile duct cancer; Cancer; Bile duct cancer

• Registration Number: ISRCTN32669229
• Lead Sponsor: niversity of Leipzig (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Two-dimensional detectable tumors or metastasis
2. Aged between 18 and 75 years
3. General condition - World Health Organisation (WHO) <2
4. Live expectancy of at least three months
5. Informed consent
6. Bilirubin not to be elevated more than upper normal value (1.5 times in the presence of liver metastasis) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 1.5 times (2.5 times in the presence of liver metastasis) of the upper normal value
7. Creatinine <133 µmol/l (<1.5 mg/l), creatinine clearance >60 ml/min

Exclusion Criteria

1. Pregnant and lactating women, fertile men and women without adequate contraception
2. Patients that have not received primary chemotherapy
3. Pre-operated tumor recurrence
4. Tumor extent >50% of the liver or >25% of the lung, abdominal mass >10 cm, Central Nervous System (CNS) metastasis
5. Ileus
6. Non-measurable tumor
7. Known intolerance to imatinib and its preservatives
8. Second malignancy
9. Second unstable disease
10. Co-medication with non-approved drugs
11. Any other anti-cancer treatment
12. Co-medication with paracetamol

Study & Design

• Study Type: Interventional
• Study Design: Not specified