Palliative Chemotherapy (2nd line) with Imatinib (Glivec™) in Patients with Bile Duct Cancer
| ISRCTN | ISRCTN32669229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32669229 |
| Secondary identifying numbers | CSTI571BDE55 |
- Submission date
- 02/02/2006
- Registration date
- 27/02/2006
- Last edited
- 01/09/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marcus Wiedmann
Scientific
Scientific
Philipp-Rosenthalstr. 27
Leipzig
04103
Germany
| Phone | +49 (0)34 1971 2230 |
|---|---|
| wiedm@medizin.uni-leipzig.de |
Study information
| Study design | Non-randomised open label multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | GlivecGG |
| Study objectives | The aim is to assess the pharmacokinetics and efficacy of imatinib in patients with bile duct cancer and to test Positron Emission Tomography (PET) as a diagnostic tool. |
| Ethics approval(s) | Approved by the Local Ethics Committee of Leipzig University on 28 November 2005. |
| Health condition(s) or problem(s) studied | Non-resectable bile duct cancer |
| Intervention | 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 administration and during the following weeks 3. Assessment of the efficacy of PET for evaluation of early treatment response Added 01/09/09: trial was stopped prematurely due to a lack of a sufficient number of patients (9 in three and a half years). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Imitanib (Glivec) |
| Primary outcome measure | 1. Response rate 2. Median duration of objective remission |
| Secondary outcome measures | 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 |
| Overall study start date | 01/03/2006 |
| Completion date | 28/02/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 - recruitment closed on 31/08/09 (9 recruited). |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Philipp-Rosenthalstr. 27
Leipzig
04103
Germany
04103
Germany
Sponsor information
University of Leipzig (Germany)
University/education
University/education
Ritterstr. 26
Leipzig
04109
Germany
| wiedm@medizin.uni-leipzig.de | |
"ROR" |
https://ror.org/03s7gtk40 |
Funders
Funder type
Industry
Novartis Pharma GmbH (Germany)
No information available
Business Unit Oncology (Geschäftseinheit Onkologie) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
