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Gemcitabine With or Without Sorafenib 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.
ClinicalTrials.gov Identifier: NCT00541021
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 8, 2007
Last Update Posted : December 15, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine hydrochloride Drug: sorafenib tosylate Phase 3

Detailed Description:



  • Compare progression-free survival.


  • Compare toxicities.
  • Compare response rate.
  • Compare overall survival.
  • Evaluate clinical benefits.
  • Compare quality of life.
  • Identify biomarkers that predict therapeutic response.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sorafenib tosylate twice daily and gemcitabine hydrochloride IV once weekly for 7 weeks followed by 1 week of rest (course1). For the next 2 courses, patients receive gemcitabine hydrochloride weekly for 3 weeks followed by 1 week of rest and sorafenib tosylate twice daily.
  • Arm II: Patients receive oral placebo twice daily and gemcitabine hydrochloride as in arm I.

After completing 3 courses of therapy, patients in both arms who have stable or responding disease may continue to receive sorafenib tosylate or placebo in the absence of disease progression or unacceptable toxicity.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.
Study Start Date : December 2006
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Toxicities
  2. Response rate
  3. Overall survival
  4. Clinical benefits
  5. Quality of life by QLQ-C30
  6. Biomarkers of response

Information from the National Library of Medicine

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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:

  • Diagnosis of adenocarcinoma of the pancreas

    • Locally advanced or metastatic disease
  • Measurable disease, defined as at least 1 lesion measurable by RECIST criteria

Exclusion criteria:

  • Brain metastases


Inclusion criteria:

  • WHO performance status 0-2
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Creatinine < 1.5 times normal
  • Transaminases < 2 times normal (5 times normal if liver metastases)
  • Total bilirubin < 1.5 times normal
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Pregnant or nursing
  • Intestinal occlusion
  • Prior inflammatory intestinal disease
  • Crohn's disease
  • Hemorrhagic rectal colitis
  • Peripheral neuropathy > grade 2
  • Other severe illness, including any of the following:

    • Unstable cardiac disease, even if treated
    • Psychological or neurological disease including dementia
    • Uncontrolled active infection
    • Other severe illness that would compromise study participation
  • Impossible to receive study therapy due to geographical, social, or psychological reasons
  • Other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix


Inclusion criteria:

  • See Disease Characteristics
  • At least 6 months since prior chemotherapy or radiochemotherapy
  • At least 4 weeks since prior radiotherapy and/or surgery

Exclusion criteria:

  • Prior therapy for advanced disease
  • Prior inhibitors of kinase signaling (e.g., ras/raf, MEK, AKT, mTOR, or farnesyl transferase)
  • Prior inhibitors of angiogenesis (e.g., bevacizumab)
  • Prior organ graft or allogeneic transplantation
  • Prior extensive intestinal resection
  • Concurrent participation in another therapeutic study
  • Concurrent inductors of CYP3A4 (e.g., barbiturates, anti-epileptics, or rifampicin)

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 ClinicalTrials.gov identifier (NCT number): NCT00541021

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Frederic Viret, MD    33-4-91-22-35-37    viretf@marseille.fnclcc.fr   
Sponsors and Collaborators
Institut Paoli-Calmettes
OverallOfficial: Frederic Viret, MD Institut Paoli-Calmettes

ClinicalTrials.gov Identifier: NCT00541021     History of Changes
Other Study ID Numbers: CDR0000564099
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
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