Status:
COMPLETED
Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic Cancer
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborating Sponsors:
Professor Cunningham's Clinical Research Fund
Hoffmann-La Roche
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Pancreatic cancer is an aggressive, largely chemo-resistant disease with a poor prognosis. EGFR and VEGF are both overexpressed in pancreatic cancers and thought to contribute to tumour development an...
Detailed Description
To establish the safety and efficacy of a combination of four drugs (capecitabine, gemcitabine, erlotinib and bevacizumab) in the treatment of patients with locally advanced or metastatic pancreatic c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced or metastatic disease
- Not amenable to curative resection
- No invasion of adjacent organs (e.g., duodenum or stomach) by CT scan
- Unidimensionally measurable disease as assessed by CT in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
- No evidence of brain metastasis
- PATIENT CHARACTERISTICS:
- Age:
- 18 and over
- Performance status:
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy:
- Greater than 3 months
- Hematopoietic:
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic:
- Bilirubin ≤ upper limit of normal
- Serum albumin \> 26 g/litre
- Renal:
- Creatinine ≤ 180 micromoles/litre OR
- Creatinine clearance ≥ 50 mL/min
- Cardiovascular:
- No clinically significant cardiovascular disease
- No uncontrolled hypertension (i.e., blood pressure \> 150/90 mm Hg on medication)
- No arterial thromboembolic event within the past 6 months, including any of the following:
- Myocardial infarction
- Unstable angina pectoris
- Cerebrovascular accident
- Transient ischemic attack
- No New York Heart Association grade II-IV congestive heart failure
- No serious cardiac arrhythmia requiring medication
- OTHER:
- Not pregnant or breast feeding
- Fertile patients must use effective contraception during study participation
- No serious or non-healing wound, ulcer, or bone fracture
- No infection requiring parenteral antibiotics
- No major bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
- No surgery within the last 28 days or anticipation for the need for major surgery during the course of study treatment
- No other active malignancy except non-melanoma skin cancer and cervical cancer in-situ
- No history of known dihydropyrimidine dehydrogenase (DPD) deficiency
- No lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication
- PRIOR CONCURRENT THERAPY:
- No previous chemotherapy, radiotherapy or other investigational drug treatment for metastatic disease (including VEGF or EGFR antagonists)
- No previous preoperative or adjuvant chemotherapy, radiotherapy or other investigational drug treatment.
- No full dose anti-coagulation (i.e. warfarin or full dose low molecular weight heparin) prior to starting study treatment.
- No ongoing treatment with aspirin (\>325 mg/day) or other medications known to predispose to gastrointestinal ulceration
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00260364
Start Date
November 1 2005
End Date
August 1 2011
Last Update
October 14 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Royal Marsden Foundation Hospital NHS Trust
London and Surrey, London, United Kingdom, SM2 5PT