Avastin and Tarceva for Upper Gastrointestinal Cancers

NCT00350753 | Completed Phase 2

• 2 other identifiers: EB-UGI-012006-001308-35
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

Erlotinib and bevacizumab have shown activity individually, as single drugs, or in combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers indicating an important role of EGF and VEGF have been found in these tumors, and in cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers, justifying an experimental phase II-study of patients with these diagnoses, refractory or intolerant to standard systemic therapy.

Conditions

Cholangiocarcinoma; Gallbladder Cancer

Keywords

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (2)

• Objective response by RECIST criteria

  From time of treatment start to response evaluation

• Time to progression

  1 year

Secondary Outcomes (3)

• Toxicity evaluated by NCI-CTCae version 3.0

  1 year

• Survival

  1 year

• Biomarkers

  6 months

Study Arms (1)

Erlotinib and bevacizumab

EXPERIMENTAL

Drug: Erlotinib and bevacizumab

Interventions

Erlotinib and bevacizumab DRUG

Erlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days

Erlotinib and bevacizumab

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically verified carcinoma of the gall bladder or bile ducts.
• PS 0-1 (ECOG scale)
• Age \> 18 years
• Life expectancy \> 3 months
• Sufficient organ function, defined as:
• Platelets \> 100 x 109/liter
• Leukocytes \> 3,0 x 109/liter
• ACN \> 1,5 x 109/liter
• ASAT and/or ALAT \< 3 x upper normal limit
• Bilirubin \< 1,5 x upper normal limit
• EDTA clearance \> 45 ml/min
• APTT and INR \< normal limit
• Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.

You may not qualify if:

• Radiotherapy or chemotherapy within the last 4 weeks
• Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
• Any prior EGFR- or VEGFR-based therapy
• Any condition (medical, social, psychological), which would prevent adequate information and follow-up
• Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
• Any other active malignancy, except basal or squamous cell carcinoma of the skin, or carcinoma in situ
• Any significant cardiac disease (New York Heart Association Class II or greater), significant arrythmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris
• Clinically significant peripheral vascular disease
• Evidence of coagulopathy
• Use of ASA, NSAIDs or clopidogrel
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, anticipation of need for major surgical procedure during the curse of the study
• o Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to treatment
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to treatment
• Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound or ulcer
• Pregnancy or breast feeding

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator

Study Sites (3)

Århus Sygehus

Aarhus, 8000 C, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

Erlotinib Hydrochloride; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ulrik Lassen, MD., PH.D.

  Rigshospitalet, Dept. of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 11, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 15, 2009

Record last verified: 2009-07

Locations

DK (3)