Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 and progression. The combination of gemcitabine and capecitabine has recently been shown to be effective in advanced pancreatic cancer. The combination of gemcitabine plus erlotinib has also been shown to be effective in advanced pancreatic cancer. The aim of this study is to assess whether combining a chemotherapy doublet (gemcitabine plus capecitabine) and a biologic doublet (erlotinib plus bevacizumab) is a safe and effective way to treat advanced pancreatic cancer by targeting multiple tumour stimulating mechanisms simultaneously.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: Hoffmann-La Roche; Professor Cunningham's Clinical Research Fund
• Treatments: Bevacizumab; Capecitabine; Erlotinib Hydrochloride; Gemcitabine

Criteria

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