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Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer

Phase 2
18 Years
Not Enrolling
Biliary Tract Cancer, Gallbladder Cancer

Thank you

Trial Information

Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer

Inclusion Criteria:

- Histologically confirmed metastatic or unresectable Kras and Braf wild-type biliary
tract adenocarcinoma (bile ducts, hepatic duct, cystic duct, common bile duct,
ampulla of Vater or gallbladder adenocarcinoma).

- Screening for tumor Kras and Braf mutations requires formalin fixed paraffin embedded
tumor blocks from core needle excisional biopsy.

- Participants must have measurable disease.

- No prior chemotherapy for biliary tract or gallbladder cancer. Prior
chemoembolization or radiation to the liver allowed as long as measurable disease
outside chemoembolization or radiation area and other baseline characteristics met
and at least 4 weeks has lapsed since therapy. No prior gemcitabine or oxaliplatin
or anti-EGFR therapies including panitumumab therapy allowed.

- Age minimum 18 years old.

- Life expectancy of greater than 3 months.

- ECOG performance status < 1

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

- Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL
hemoglobin > 9mg/dL Mg > 1.2 mEq/L total bilirubin < 2.5 mg/dL AST (SGOT)/ALT (SGPT)
< 2.5 X institutional upper limit of normal (unless liver is involved with tumor, in
which case the transaminases must be 5 x upper limits of normal), creatinine within
normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects
with creatinine levels about institutional normal

- Patients with concurrent malignancy may be included if disease is characterized by
one of the following definitions: 1. Malignancy treated with curative intent and
with no known active disease present for 3 years prior to randomization and felt to
be at low risk for recurrence by the treating physician. 2. Adequately treated
non-melanomatous skin cancer or lentigo maligna without evidence of disease. 3.
Adequately treated cervical carcinoma in situ without evidence of disease. 4.
Prostatic intraepithelial neoplasia without evidence of prostate cancer. 5. DCIS
without evidence of breast cancer.

- Ability to understand and the willingness to sign a written informed consent

- Patients may have prior placement of stents or shunts to relieve biliary obstruction.

Exclusion Criteria:

- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to
entering the study or those who have not recovered from adverse events due to agents
administered more than 4 weeks earlier.

- Participants may not be receiving any other study agents.

- Participants with known brain metastases.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gemcitabine, oxaliplatin or panitumumab.

- Patients with preexisting peripheral neuropathy of grade 2 or greater severity
according to the Common Terminology Criteria of the NCI (version 3.0) are ineligible.

- Patients with biliary obstruction with inadequate drainage and total bilirubin > 2.5
mg/dL are ineligible.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements,

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan.

- Known positive test(s) for HIV, hepatitis C virus, acute or chronic active hepatitis
B infection.

- Pregnant women are excluded.

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:

To determine the radiographic response rate of GEMOX-Panitumumab (GEMOX-P) in chemotherapy naïve KRAS/ BRAF wild type stage IV BTC

Outcome Description:

Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.

Outcome Time Frame:

Evaluation at every 8 weeks and thereafter. Responses must be

Safety Issue:


Principal Investigator

Aram Hezel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

January 2013

Related Keywords:

  • Biliary Tract Cancer
  • Gallbladder Cancer
  • Unresectable
  • metastatic
  • biliary tract
  • gallbladder cancer
  • Gallbladder Neoplasms
  • Biliary Tract Neoplasms



University of Rochester Medical Center Rochester, New York  14642
Dana-Farber / Harvard Cancer Center Boston, Massachusetts  02215