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A Multicenter Phase II Study of Gemcitabine, Capecitabine and Bevacizumab for Locally Advanced or Metastatic Adenocarcinoma of the Gall Bladder or Biliary Ducts.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cholangiocarcinoma

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Trial Information

A Multicenter Phase II Study of Gemcitabine, Capecitabine and Bevacizumab for Locally Advanced or Metastatic Adenocarcinoma of the Gall Bladder or Biliary Ducts.


The primary objective of this study is to assess progression free survival with proposed
therapy for patients with locally advanced or metastatic adenocarcinoma of the gallbladder
or biliary ducts.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed gallbladder or biliary
tract adenocarcinoma that is unresectable or metastatic, or metastatic adenocarcinoma
which is radiologically confirmed to be of gallbladder or biliary origin. No prior
systemic therapy for metastatic disease. Prior adjuvant therapy is permitted if
completed over 6months ago.

- Age ≥ 18 years. Because no dosing or adverse event data are currently available on
the use of bevacizumab in combination with gemcitabine in patients over 18 years of
age, children are excluded from this study, but will be eligible for future pediatric
phase 1 combination trials.

- ECOG performance status 0 or 1.

- Life expectancy > 3 months.

- Patients must have normal organ and marrow function as defined below:

- leukocytes ≥ 3,000/microL

- absolute neutrophil count ≥ 1,500/microL

- platelets ≥ 1OO,OOO/microL

- total bilirubin ≤ 2 mg/dl

- AST or ALT ≤ 5 times upper limit of normal (UNL) for subjects with documented
liver metastases; ≤ 2.5 times UNL for subjects without evidence of liver
metastases.

- creatinine < 1.5 mg/dL or 24 hour urine creatinine clearance > 50 ml/min.

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately.

- Signed, written informed consent document.

- Patient must have measurable disease

Exclusion Criteria:

- Subjects meeting any of the following criteria are ineligible for study entry:

- Compromised renal or hepatic function.

- Screening clinical laboratory values INR ≥ 1.5 (except those subjects who are
receiving full-dose warfarin)

- Hemoglobin < 9 gm/dL (may be transfused or receive epoetin alfa (e.g., Epogen@) to
maintain or exceed this level).

- Bevacizumab risk factors: History of serious systemic disease, including uncontrolled
hypertension (blood pressure of greater than 160/110 mmHg on medication), prior
history of hypertensive crisis or hypertensive encephalopathy, unstable angina, New
York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable
symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia,
i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible),
or clinically significant peripheral vascular disease (Grade II or greater).

- Presence of central nervous system or brain metastases.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of the study; fine needle aspirations or core biopsies within 7 days prior to
Day O.

- Pregnancy (positive pregnancy test) or lactation.

- 24 hour urine creatinine clearance < 50 ml/min or urine protein/creatinine ratio
greater than or equal to 1.0 at screening.

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

- Evidence of bleeding diathesis or coagu1opathy.

- Recent (less than or equal to six months) arterial thromboembolic events, including
transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or
myocardial infarction (MI).

- Inability to comply with study and/or follow-up procedures.

- Patients with known duodenal or gastric wall involvement should be excluded.

- Patients with suspected involvement of stomach or duodenum should have screening
endoscopies to exclude the same prior to therapy.

- Patients with esophageal or gastric varices.

- Patients with recent hemoptysis (within 1 week).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary objective of this study is to assess progression free survival (PFS) with proposed therapy for patients with locally advanced or metastatic gallbladder and biliary cancers.

Outcome Time Frame:

every 9 weeks

Safety Issue:

Yes

Principal Investigator

Renuka Iyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 150509

NCT ID:

NCT01007552

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Cholangiocarcinoma
  • Biliary Duct Cancer
  • Cancer of the Gallbladder
  • Adenocarcinoma of the Gall Bladder
  • Adenocarcinoma of the Biliary Ducts
  • Cholangiocarcinoma
  • Extrahepatic cholangiocarcinoma
  • Adenocarcinoma
  • Gallbladder Neoplasms
  • Cholangiocarcinoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Ohio State UniversityColumbus, Ohio  43210