Advanced Pancreatic Cancer - either locally advanced disease not amenable to curative resection and metastatic disease. MedDRA version: 9.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable MedDRA version: 9.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable
Conditions
Interventions
Product Name: Gemzar
Product Code: Gemcitabine
Pharmaceutical Form: Injection*
Concentration unit: mg/g milligram(s)/gram
Concentration
Sponsors
Royal Marsden Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed adenocarcinoma of the pancreas - Prescence of locally advanced or metatatic disease precluding curative surgical resection. - Measurable disease by CT in accordance with RECIST guidelines. - No prior chemotherapy, radiotherapy or other ionvestigational drug treatment for this indication. - Performance Status 0-2 - Adequate haematological/biochemical parameters - Informed written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Uncontrolled hypertension - Clinically significant cardiovascular disease i.e. myocardial infarction within 6 motnhs - Intra-cerebral metastases - Postive margins following resection or residual disease not amounting to measurable disease (R1 and R2 resections) Major surgical procedure within the previuos 28 days. - Commencement on anti-coagulant within 10 days prior to starting treatment. -Pregnancy or breast feeding. - Major bleeding diathesis or coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: Phase I In view of the potential overlapping toxicity bewteen capecitabine and erlotinib, to define the maximum tolerated dose (MTD) of capecitabine in this four drug combination (capecitabine, erlotinib, bevacizumab and gemcitabine). The doses of the other drugs will not be escalated. A 3 + 3 standard dose finding expanded cohort dose escalation methodology will be used for this part of the study with pre-defined dose limiting toxicities. Part B: Phase II After selection of a recommended dose for capecitabine based on the MTD established in Part A, to further assess the efficacy and safety of the four drug combination (capecitabine, erlotinib, bevacizumab and gemcitabine). This cohort will be expanded to a total of 40 patients inclusive of those patients recruited in part A. ; Secondary Objective: Part A and B: To characterise the safety profile of the drug regimen based on toxicity, quality of life and pain assessments. Part B To evaluate secondary efficacy measures including one year and overall survival, time to progression and disease control rate. The patients from part A will also be eligible for efficacy assessment. ; Primary end point(s): Part A: To define the MTD of capecitabine in this four drug combination Part B: Overall response rate of the four drug combination (inclusive of part A as these patients will be asessable for efficacy also). | — |
Countries
United Kingdom
Outcome results
None listed