Targeted therapy in patients with advanced pancreatic cancer
| ISRCTN | ISRCTN70474205 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70474205 |
| Secondary identifying numbers | UKF000577 |
- Submission date
- 11/03/2008
- Registration date
- 30/05/2008
- Last edited
- 30/05/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Prof Michael Geissler
Scientific
Scientific
Municipal Hospital Esslingen
Department of Medicine, Gastroenterology and Oncology
Esslingen
73730
Germany
Study information
| Study design | Prospective, open, one-armed multicentric phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 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 | A prospective, non-randomised phase II study of trastuzumab and capecitabine in patients with HER2 expressing advanced pancreatic cancer |
| Study objectives | Pancreatic cancer is the fourth most common cause of cancer related death in Western countries. Advantages in surgical techniques, radiation and chemotherapy had almost no impact on the long term survival of affected patients. Therefore, the need for better treatment strategies is urgent. HER2, a receptor tyrosin kinase of the epidermal growth factor receptor (EGFR) family, involved in signal transduction pathways leading to cell growth and differentiation is overexpressed in a number of cancers, including breast and pancreatic cancer. While in breast cancer HER2 has already been successfully used as a treatment target, there are no studies thus far evaluating the effects of inhibiting HER2 tyrosine kinases in patients with pancreatic cancer. |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of the University of Freiburg, Germany on the 19th April 2004. |
| Health condition(s) or problem(s) studied | Advanced pancreatic cancer (stage IVb) |
| Intervention | The trastuzumab loading dose of 4 mg/kg body weight will be given on day one over 90 minutes. For maintenance therapy a weekly dose of 2 mg/kg body weight over 30 minutes will be infused until tumour progression takes place. Patients will be monitored closely for six hours during the first dose of trastuzumab and for two hours after the following rastuzumab infusions to rule out adverse reactions. Capecitabine will be applied orally twice daily at a dose of 1250 mg/m^2 on day 1 - 14 followed by a break of seven days. The three weeks cycles will be repeated until tumour progression or until a grade three to four toxicity occurs. Planned duration of treatment 12 weeks or until disease progression. In the case of stable disease treatment is continued until progression. Follow up is performed until death. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Trastuzumab, rastuzumab, capecitabine |
| Primary outcome measure | Progression free survival after 12 weeks. |
| Secondary outcome measures | 1. Progression free survival time 2. Overall survival 3. Time until remission (partial or complete) 4. Duration of remission 5. Rate of 'clinical benefit response' after 12 weeks 6. Quality of life before treatment and after two cycles of chemotherapy Additional secondary trial endpoints: 7. Toxicity analysis 8. The rate of adverse events 9. The relationship between progression free survival and CA19-9 plasma levels 10. The relation between HER2/neu overexpression and progression free survival |
| Overall study start date | 01/06/2004 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 37 |
| Key inclusion criteria | 1. Written informed consent 2. Aged 18 years or older, either sex 3. Histological verified pancreatic cancer in stage IVb (T1-4N0M1) 4. Staging and CA19-9 serum level not older than four weeks 5. Histological verified over-expression of HER2/neu (immunological score 3+ or 2+ with verification by fluorescent in situ hybridisation [FISH]) 6. At least one measurable lesion (greater than or equal to 2 cm in conventional computed tomography [CT] scan or greater than or equal to 1 cm in spiral CT scans) 7. No prior chemotherapy 8. No prior radiotherapy 9. Performace-status 0 - 2 according to World Health Organization [WHO]/Eastern Cooperative Oncology Group [ECOG] or greater than or equal to 60 points on the Karnofsky scale 10. Life expectancy of at least three months 11. Left ventricular excretion fraction greater than 50% 12. Appropriate renal, liver and haematopoetic function defined by: 12.1. Neutrophils greater than or equal to 1.5 x 10^9/l 12.2. Haemoglobin greater than or equal to 80 g/l 12.3. Platelets greater than or equal to 100 x 10^9/l 12.4. Total bilirubin less than 3 x normal 12.5. Creatinine clearance greater than or equal to 30 ml/min (Cockroft Gault) 12.6. Transaminases either less than 2.5 x normal, or less than 5 x normal in case of liver metastasis 13. Possibility of long-term follow up 14. Negative pregnancy testing |
| Key exclusion criteria | 1. Possible surgical resection and/or radiotherapy with curative potential 2. Dihydropyrimidine-dehydrogenase deficiency 3. Gastrointestinal obstruction 4. A known secondary neoplasm except a curative treatable basalioma of the skin or carcinoma in situ of the cervix uteri 5. A known hypersensitivity against any of the applied substances 6. Clinically relevant disorder of the cardiovascular system or other organs or a severe systemic disease that compromises the study protocol or the interpretation of the data 7. Clinically manifest pulmonary disorder 8. Prior polyneuropathy 9. A concomitant treatment with the virustatic agents sorivudin or its analogues 10. Pregnancy, breast feeding or absence of appropriate contraceptive measures 11. Psychiatric disorders, drug abuse or other disorders, that compromise the informed consent 12. Concomitant participation in other clinical trials or participation within the last four weeks 13. Any other disorder or treatment that poses a risk to the patient or is incompatible with the aims of this study |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Municipal Hospital Esslingen
Esslingen
73730
Germany
73730
Germany
Sponsor information
Roche Pharma AG (Germany)
Industry
Industry
Emil-Barell-Str. 1
Grenzach-Wyhlen
79639
Germany
| Website | http://www.roche.de |
|---|---|
"ROR" |
https://ror.org/00sh68184 |
Funders
Funder type
Industry
Roche Pharma AG (Germany) - providing chemotherapeutic agents
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 |
