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

NCT00260364 | Completed Phase 1 DMC

• 2 other identifiers: CCR2631EudraCT No.: 2005-002715-24
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatic Cancer

Keywords

Recurrent carcinoma of the pancreas; Adenocarcinoma of the pancreas; Stage II carcinoma of the pancreas; Stage III carcinoma of the pancreas; Stage IVA carcinoma of the pancreas; Stage IVB carcinoma of the pancreas

Outcome Measures

Primary Outcomes (2)

• Part A (Phase I): Dose-limiting Toxicity (DLT)

• Part B (Phase II): Overall response rate (complete response and partial response)

Secondary Outcomes (4)

• The secondary efficacy objectives of the trial are: One year survival and median overall survival

• Progression free survival, Disease control rate.

• The secondary safety objectives are: Toxicity,Quality of life

• and Assessment of pain

Interventions

Gemcitabine 1000 mg/m2 iv days 1, 8, 15 of a 28 day cycle DRUG

Capecitabine orally days 1 -21 DRUG

Erlotinib 100 mg orally days 1-28 DRUG

Bevacizumab 5 mg/kg intravenously every 2 weeks DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Professor Cunningham's Clinical Research Fund: collaborator
• Hoffmann-La Roche: collaborator

Study Sites (1)

The Royal Marsden Foundation Hospital NHS Trust

London and Surrey, London, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Erlotinib Hydrochloride; Bevacizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David Cunningham, MD, FRCP

  The Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 14, 2016

Record last verified: 2010-01

Locations

GB (1)