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Avastin and Tarceva for Upper Gastrointestinal Cancers

Primary Purpose

Cholangiocarcinoma, Gallbladder Cancer

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Erlotinib and bevacizumab
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 Ongoing therapeutic anti-coagulation Hypertension with blood pressure > 150/100 mmHg

Sites / Locations

  • Rigshospitalet
  • Odense University Hospital
  • Århus Sygehus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib and bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

Objective response by RECIST criteria
Time to progression

Secondary Outcome Measures

Toxicity evaluated by NCI-CTCae version 3.0
Survival
Biomarkers

Full Information

First Posted
July 10, 2006
Last Updated
July 14, 2009
Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00350753
Brief Title
Avastin and Tarceva for Upper Gastrointestinal Cancers
Official Title
A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital

4. Oversight

5. Study Description

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.
Detailed Description
Primary Objective To determine the median time to progression (TTP) and response rate (RR) of the combination of erlotinib and bevacizumab in patients with advanced upper gastro-intestinal carcinomas, refractory or intolerant to standard systemic therapy. Secondary Objective To determine safety, tolerability and toxicity. To determine median and overall survival (OS). To correlate efficacy of treatment with the expression of tumor markers obtained in serum (EFGR, bFGF, p-VEGF-A, and sVEGF-R2), in paraffin embedded tumor tissue (micro vessel density (MVD), and expression of VEGFR and EGFR, after immunostaining), and in fresh frozen tumor biopsies (micro array-based analyses of patterns of gene expression). Treatment: Bevacizumab (AvastinÒ) will be given intravenously at 10 mg/kg every other week. Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Gallbladder Cancer
Keywords
Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib and bevacizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Erlotinib and bevacizumab
Intervention Description
Erlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days
Primary Outcome Measure Information:
Title
Objective response by RECIST criteria
Time Frame
From time of treatment start to response evaluation
Title
Time to progression
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Toxicity evaluated by NCI-CTCae version 3.0
Time Frame
1 year
Title
Survival
Time Frame
1 year
Title
Biomarkers
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Ongoing therapeutic anti-coagulation Hypertension with blood pressure > 150/100 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Lassen, MD., PH.D.
Organizational Affiliation
Rigshospitalet, Dept. of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Århus Sygehus
City
Århus
ZIP/Postal Code
8000 C
Country
Denmark

12. IPD Sharing Statement

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Avastin and Tarceva for Upper Gastrointestinal Cancers

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