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A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors

Phase 2
18 Years
Not Enrolling
Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Gastrointestinal Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

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Trial Information

A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors


I. Evaluate the objective response rate in patients with metastatic or unresectable
cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride.


I. Evaluate time to progression in these patients.

II. Evaluate overall and progression-free survival of these patients.

III. Evaluate the adverse events associated with this regimen. OUTLINE: This is an
open-label, multicenter study.

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and oral
erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of
unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 3 years.

Inclusion Criteria


- Absolute neutrophil count >= 1,500/mm3

- Histologically or cytologically confirmed cholangiocarcinoma or gallbladder

- Metastatic or surgically unresectable disease

- Measurable disease, defined as >= 1 lesion whose longest diameter can be accurately
measured as >= 2.0 cm with conventional techniques or as > 1.0 cm with spiral CT

- Spiral CT scan imaging must be used for pre- and post-treatment tumor
measurements of lesions measuring >= 1.0 cm to < 2.0 cm

- Clinical lesions will only be considered measurable when they are superficial

- Lesions on chest x-ray are acceptable as measurable lesions when they are
clearly defined and surrounded by aerated lung

- No ampulla of Vater tumors

- No evidence of CNS disease

- Life expectancy >= 3 months

- ECOG performance status 0-2

- Platelet count >= 75,000/mm3

- Total bilirubin =< 2 times ULN

- ALT and AST =< 2.5 times ULN

- Creatinine =< 2 mg/dL

- Albumin >= 2.5 g/dL

- Alkaline phosphatase =< 5 times ULN

- Urine protein:creatinine ratio < 1.0 OR 24-hour urine protein < 1000 mg

- No concurrent illness or medical condition, including any of the following:

- Impairment of gastrointestinal (GI) function or disease that may significantly
alter the absorption of erlotinib hydrochloride

- Requirement for IV alimentation

- No concurrent illness or medical condition, including any of the following:

- Active peptic ulcer disease;

- Serious or nonhealing wound, ulcer, or bone fracture;

- GI bleed that required procedural intervention within the past 3 months

- No concurrent illness or medical condition, including any of the following:

- Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28

- Ongoing or active infection

- Symptomatic congestive heart failure

- Psychiatric illness or social situation that would limit study compliance

- No other malignancy within the past 3 years

- No abnormalities of the cornea

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No clinically significant cardiovascular disease

- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas
or mitomycin C) and recovered

- No significant traumatic injury within the past 28 days

- No prior systemic anticancer therapy for metastatic gallbladder or bile duct cancer

- More than 28 days since prior major surgery [Note: Insertion of a vascular access
device is not considered major/minor surgery]

- More than 2 weeks since prior minor surgery [Note: Insertion of a vascular access
device is not considered major/minor surgery]

- More than 7 days since prior core biopsy

- No concurrent major surgery

- No other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy
or supportive care considered investigational

- No concurrent enzyme-inducing antiepileptic drugs or any other CYP3A4 inducer, such
as rifampin or Hypericum perforatum

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents or other concurrent anticancer therapies

- No concurrent prophylactic hematopoietic colony-stimulating factors

- Concurrent full-dose anticoagulants allowed provided PT/INR is > 1.5 and both of the
following criteria are met:

- In-range INR on a stable dose of oral anticoagulant OR on a stable dose of low
molecular weight heparin

- AND (continued from above) No active bleeding or pathological condition that carries
a high risk of bleeding (e.g., tumor involving major vessels, gastrointestinal
ulcerations, or known varices)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Confirmed Tumor Responses.

Outcome Description:

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions. A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint.

Outcome Time Frame:

After 6 courses of treatment. Each course lasts 28 days.

Safety Issue:


Principal Investigator

William Schelman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

February 2009

Related Keywords:

  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Cholangiocarcinoma of the Gallbladder
  • Gastrointestinal Cancer
  • Recurrent Extrahepatic Bile Duct Cancer
  • Recurrent Gallbladder Cancer
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer
  • Biliary Tract Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma
  • Gastrointestinal Neoplasms



Mayo Clinic Rochester, Minnesota  55905