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A Phase I/II Study of Combination of Gemcitabine, Oxaliplatin and Sorafenib (GEMOX-Sorafenib) in Patients With Advanced Biliary Tract Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Cholangiocarcinoma, Biliary Tract Cancer, Gallbladder Cancer

Thank you

Trial Information

A Phase I/II Study of Combination of Gemcitabine, Oxaliplatin and Sorafenib (GEMOX-Sorafenib) in Patients With Advanced Biliary Tract Cancer

Inclusion Criteria:

- Age >= 18 years

- Histologically or cytologically confirmed biliary tract or gallbladder carcinoma

- Any stage of disease is allowed but the patients must not be candidates for curative

- ECOG performance status 0-1 in Ph I

- ECOG performance status 0-2 in Ph II. Patients with ECOG PS of 2 will only be
enrolled if they will comprise at most 25% of the total accruals. This will be
monitored in real time to ensure that at any point during accrual, PS 2 patients will
comprise <= 25% of the total accruals

- Patients must have normal organ and marrow function as defined below within 14 days
of study entry:

- Absolute neutrophil count >= 1,500 cells/mm3

- Platelet count >= 60,000/mm3

- Creatinine < 1.5 upper limit of normal.

- AST and ALT <= 2.5 x ULN

- Bilirubin <= 3.0 mg/dl

- INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation
treatment with an agent such as warfarin will not be candidates for the trial.
Patients on anticoagulation with low molecular weight or heparinoids are
protocol candidates.

- Any number of previous lines of chemotherapy is allowed for the phase I portion

- During the phase II trial, no prior chemotherapy for inoperable or metastatic disease
is allowed except 5-FU or Capecitabine as radiosensitizers. Prior adjuvant
chemotherapy is allowed.

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment

- Women of childbearing potential and men must agree to use adequate contraception
(barrier method of birth control) prior to study entry and for the duration of study
participation. Men should use adequate birth control for at least three months after
the last administration of sorafenib.

- Ability to understand and the willingness to sign a written informed consent. A
signed informed consent must be obtained prior to any study specific procedures.

- Life expectancy of greater than 12 weeks

Exclusion Criteria:

- Investigational agents within 28 days prior to Day 1 of study

- Chemotherapy within 4 weeks prior to Day 1 of study

- Nitrosoureas, mitomycin-C within 6 weeks prior to Day 1 of study.

- Prior treatment with sorafenib, gemcitabine or oxaliplatin

- Prior history of peripheral neuropathy > Grade 1 (e.g., diabetic neuropathy)

- Pregnant or breast-feeding female

- Patients with a history of allergic reactions or sensitivity attributed to compounds
of similar chemical or biologic composition to sorafenib, oxaliplatin or gemcitabine

- Patients with GI tract disease resulting in an inability to take oral medication,
malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures
affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative

- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have
unstable angina (anginal symptoms at rest) or new onset angina (began within the last
3 months) or myocardial infarction within the past 6 months.

- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management.

- Known brain metastasis. Patients with neurological symptoms must undergo a CT
scan/MRI of the brain to exclude brain metastasis.

- Known human immunodeficiency virus (HIV) infection and Hepatitis B and Hepatitis C.

- Active clinically serious infection > CTCAE Grade 2.

- Arterial thrombotic/embolic events like myocardial infarct and cerebrovascular
accident including transient ischemic attacks within the past 6 months.

- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of
study drug.

- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
study drug.

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

- Evidence or history of bleeding diathesis or coagulopathy

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
study drug.

- Use of St. John's Wort or rifampin (rifampicin).

- Any medical condition, which in the opinion of the investigator places the patient at
an unacceptably high risk for toxicities

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:

Phase I: Establish the recommended phase II dose (RPTD) of the combination of sorafenib and GEMOX in patients with advanced biliary tract cancer (BTC).

Outcome Time Frame:

First two 14-day Phase I cycles

Safety Issue:


Principal Investigator

Peter Hosein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvelster Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

Related Keywords:

  • Cholangiocarcinoma
  • Biliary Tract Cancer
  • Gallbladder Cancer
  • Cholangiocarcinoma
  • Biliary Tract Cancer
  • Gallbladder Cancer
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Biliary Tract Neoplasms



University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136