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A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma"

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Neoplasms, Bile Duct Neoplasms

Thank you

Trial Information

A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma"

Primary Objectives

- To assess the overall safety of sorafenib when administered with "the 2DOC regimen"
capecitabine and oxaliplatin in patients with advanced or metastatic pancreas or
biliary tract cancers.

- To define the dose limiting toxicity and maximally tolerated dose of this combination.

- To assess the clinical response rate (stable, partial and complete responses) of the
combination in patients with advanced or metastatic pancreas or biliary tract cancers.

Secondary Objectives

- To define the time to progression and overall survival for patients treated with this

- To evaluate the congruency of the Adverse Events Self-Report Survey in determining
patient reported side effects of treatment

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed locally advanced
inoperable or metastatic adenocarcinoma of the pancreas or biliary tract who have not
previously received more than one systemic treatment for their disease.

- Age at least 18 years old

- ECOG performance status 0-2.

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

- WBC at least 3,000

- ANC at least 1,500

- PLT at least 100,000

- total bilirubin must be less than 2.5 x institutional upper limit of norm

- AST(SGOT)/ALT(SGPT) must be less than 5 X institutional upper limit of normal

- creatinine clearance must be greater than 50 mL/min as calculated by the
Cockroft-Gault formula

- Patients with ≤ grade 2 (CTC 3.0) neuropathy.

- At least one measurable lesion as defined by RECIST criteria

- The effects of oxaliplatin, capecitabine and sorafenib on the developing human fetus
at the recommended therapeutic dose are unknown. For this reason and because DNA
alkylating agents are known to be teratogenic, 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.

- Because the risk of toxicity in nursing infants secondary to oxaliplatin treatment of
the mother is unknown but may be harmful, breastfeeding should be discontinued if the
mother is treated with oxaliplatin.

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

Exclusion Criteria:

- No concomitant radiation therapy, or other systemic cancer therapies.

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other toxicities.

- History of allergy to platinum compounds, capecitabine, sorafenib or to antiemetics
appropriate for administration in conjunction with protocol-directed chemotherapy.

- Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection, thrombolic or embolic events such as cerebrovascular accident including
transient ischemic attacks within the past 6 months, symptomatic congestive heart
failure, unstable angina pectoris within 3 months prior to entry study, myocardial
infarction within 6 months prior to study entry, ongoing cardiac arrhythmia
(excluding atrial fibrillation), uncontrolled hypertension (systolic blood pressure >
150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management),
pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of
study drug, or 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.

- Pregnant or nursing women are excluded from this study because oxaliplatin,
capecitabine and sorafenib is a DNA alkylating agent with the potential for
teratogenic or abortifacient effects. Female patients of reproductive potential must
have a negative urine or serum pregnancy test within two weeks prior to enrolling.

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

- Because of drug interactions with sorafenib, use of St. John's Wort or rifampin
(rifampicin) is contraindicated. Patients may discontinue the use of these drugs to
become eligible for the study

- Any condition that impairs patient's ability to swallow whole pills.

- HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the
study because of possible pharmacokinetic interactions.

- Second malignancy within the past 3 years (excluding nonmelanoma skin cancer and in
situ cancers) that has not been treated with curative intent and is not currently
without evidence of disease,

- Patients with known gastrointestinal malabsorption syndromes are excluded as this
concurrent illness will affect absorption of the oral medications.

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:

safety of therapy

Outcome Time Frame:

overall study

Safety Issue:


Principal Investigator

Noelle K LoConte, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:




Start Date:

February 2008

Completion Date:

July 2010

Related Keywords:

  • Pancreatic Neoplasms
  • Bile Duct Neoplasms
  • advanced pancreatic and biliary tract carcinomas
  • Bile Duct Neoplasms
  • Neoplasms
  • Carcinoma
  • Pancreatic Neoplasms



University of Wisconsin Madison,, Wisconsin  53792-5666