Targeted therapy in patients with advanced pancreatic cancer

Completed

Conditions: Advanced pancreatic cancer (stage IVb)
Cancer
Pancreatic cancer

Registration Number: ISRCTN70474205

Lead Sponsor: Roche Pharma AG (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 37

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival after 12 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Progression free survival time<br>2. Overall survival<br>3. Time until remission (partial or complete)<br>4. Duration of remission<br>5. Rate of 'clinical benefit response' after 12 weeks<br>6. Quality of life before treatment and after two cycles of chemotherapy<br><br>Additional secondary trial endpoints:<br>7. Toxicity analysis<br>8. The rate of adverse events <br>9. The relationship between progression free survival and CA19-9 plasma levels<br>10. The relation between HER2/neu overexpression and progression free survival