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Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
First Received: November 9, 2004   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095966
  Purpose

RATIONALE: 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.

PURPOSE: 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 Intervention Phase
Pancreatic Cancer
Drug: gemcitabine hydrochloride
Drug: sorafenib tosylate
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Survival at 6 months [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Vascular endothelial growth factor, basic fibroblast growth factor, KRAS mutations, and RAF mutations [ Designated as safety issue: No ]

Study Start Date: September 2004
Estimated Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with sorafenib and gemcitabine.
  • Determine the toxicity of this regimen in these patients.

Secondary

  • Correlate pre-treatment levels of plasma vascular endothelial growth factor (VEGF), serum basic fibroblast growth factor (bFGF), urine VEGF, and urine bFGF with response, overall survival, and progression-free survival in patients treated with this regimen.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No evidence of bleeding diathesis

Hepatic

  • Bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior antiangiogenic agents

Chemotherapy

  • 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

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095966

Locations
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615-7828
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States, 49085
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1096
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Hedy L. Kindler, MD University of Chicago
  More Information

Additional Information:
Publications:
Wallace JA, Locker G, Nattam S, et al.: Sorafenib (S) plus gemcitabine (G) for advanced pancreatic cancer (PC): a phase II trial of the University of Chicago phase II Consortium. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-137, 2007.

Study ID Numbers: CDR0000391850, UCCRC-13169B, NCI-6567
Study First Received: November 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00095966     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pancrelipase
Recurrence
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Sorafenib
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Sorafenib
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009