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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32669229

Enrollment

Registered

2006-02-27

Start date

2006-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-resectable bile duct cancer Cancer Bile duct cancer

Interventions

1. Continuous second line chemotherapy with imatinib - assessment of response by tumor marker and imaging during follow-up 2. Generation of pharmacokinetic data during the first two days of drug admin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Two-dimensional detectable tumors or metastasis 2. Aged between 18 and 75 years 3. General condition - World Health Organisation (WHO) 60 ml/min

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Response rate 2. Median duration of objective remission	—

Secondary

Measure	Time frame
1. Time to progression 2. Median survival 3. Tumor response after one week or three months by 18-fluorodeoxyglucose-Positron Emission Tomography (18 FDG-PET) 4. Toxicity 5. Pharmacokinetics	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026