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Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Biliary Tract Adenocarcinoma, Gallbladder Adenocarcinoma

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Trial Information

Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer


- The chemotherapy drugs are given twice every 28 days. This 28 day period is called a
cycle of study treatment.

- Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15.
Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of
each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of
each cycle.

- The following tests and procedures will be performed on day 1 and day 15 or each cycle:
physical examination; medical history; blood work; and urine test. A PET scan will be
repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.

- Participants will continue to receive cycles of study treatment as long as their
disease does not progress and they are not experiencing any serious side effects.


Inclusion Criteria:



- Histologically confirmed, locally unresectable or metastatic biliary tract or
gallbladder adenocarcinoma. Patients must have at least one measurable lesion
outside prior radiation field.

- Zero to one prior chemotherapy for biliary tract or gallbladder cancer

- Age > 18 years

- ECOG performance status 0-2

- Life expectancy > 12 weeks

- Adequate organ and bone marrow function

Exclusion Criteria:

- Chemotherapy within past 3 weeks of initiation of therapy

- Pregnant or lactating women

- Clinically apparent central nervous system metastases or carcinomatous meningitis

- Biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL

- Concurrent malignancy of any site, except limited basal cell carcinoma or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix

- Uncontrolled serious medical or psychiatric illness

- Pre-existing peripheral neuropathy of grade 2 or greater severity according to the
Common Terminology Criteria of the NCI (version 3.0)

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study

- Blood pressure of > 150/100 mmHg

- Unstable angina

- NYHA Grade II or greater congestive heart failure

- History of myocardial infarction or stroke within 6 months

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury with 28 days
prior to Day 1, anticipation of need for major surgical procedure during the course
of the study

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to day 1

- Serious, non-healing wound, ulcer, or bone fracture

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the progression free survival of GEMOX-B regimen in patients with unresectable or metastatic biliary tract and gallbladder adenocarcinoma.

Outcome Time Frame:

TBD

Safety Issue:

No

Principal Investigator

Andrew X. Zhu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

05-349

NCT ID:

NCT00361231

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Biliary Tract Adenocarcinoma
  • Gallbladder Adenocarcinoma
  • Avastin
  • GEMOX
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Gallbladder Neoplasms

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