Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095966
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with locally advanced or metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer Drug: sorafenib tosylate Drug: gemcitabine hydrochloride Phase 2

Detailed Description:


I. Determine the objective response rate in patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with sorafenib and gemcitabine.

II. Determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with sorafenib plus gemcitabine.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer
Study Start Date : September 2004
Actual Primary Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (sorafenib tosylate and gemcitabine hydrochloride)
Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar

Primary Outcome Measures :
  1. Response rate as measured by RECIST criteria [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: From start of treatment to progression or death, assessed up to 6 months ]
    Kaplan-Meier curves will be constructed.

  2. Survival [ Time Frame: At 6 months ]
    Specific attention will be given to the six-month survival rate, for which 90% confidence intervals will be generated.

  3. Overall survival [ Time Frame: Up to 6 months ]
    Kaplan-Meier curves will be constructed

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Locally advanced or metastatic disease

      • Locally advanced disease must extend outside the boundaries of a standard radiotherapy port
  • Not amenable to curative surgery or radiotherapy
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Pleural effusion and ascites are not considered measurable lesions
    • Outside prior radiotherapy port
  • No known brain metastases
  • Performance status - ECOG 0-1
  • Performance status - Karnofsky 70-100%
  • More than 3 months
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No evidence of bleeding diathesis
  • Bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance ≥ 60 mL/min
  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active or ongoing infection
  • No other active malignancy
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No prior antiangiogenic agents
  • No prior cytotoxic chemotherapy for metastatic disease
  • At least 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior gemcitabine
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior investigational drugs
  • No prior sorafenib
  • No prior MAPK signaling agents
  • Concurrent warfarin anticoagulation allowed provided the following criteria are met:

    • Therapeutic on a stable warfarin dose
    • INR ≤ 3
    • Undergo weekly INR testing
    • No active bleeding or pathological condition that carries a high risk of bleeding
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00095966

United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Hedy Kindler University of Chicago Comprehensive Cancer Center

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00095966     History of Changes
Other Study ID Numbers: NCI-2012-02629
U01CA099118 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Vitamin B Complex
Growth Substances