Know Cancer

forgot password

A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy

Phase 2
18 Months
Not Enrolling
Cholangiocarcinoma, Gallbladder Cancer

Thank you

Trial Information

A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy

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


Bevacizumab (AvastinÃ’) 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.

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

- Pregnancy or breast feeding

- Ongoing therapeutic anti-coagulation

- Hypertension with blood pressure > 150/100 mmHg

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response by RECIST criteria

Outcome Time Frame:

From time of treatment start to response evaluation

Safety Issue:


Principal Investigator

Ulrik Lassen, MD., PH.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Dept. of Oncology


Denmark: Danish Medicines Agency

Study ID:




Start Date:

June 2006

Completion Date:

June 2009

Related Keywords:

  • Cholangiocarcinoma
  • Gallbladder Cancer
  • Cholangiocarcinoma
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Gastrointestinal Neoplasms