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Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: October 5, 2007   Last Updated: July 7, 2009   History of Changes
Sponsored by: Institut Paoli-Calmettes
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00541021
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: gemcitabine hydrochloride
Drug: sorafenib tosylate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicities [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Clinical benefits [ Designated as safety issue: No ]
  • Quality of life by QLQ-C30 [ Designated as safety issue: No ]
  • Biomarkers of response [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: December 2006
Detailed Description:

OBJECTIVES:

Primary

  • Compare progression-free survival.

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541021

Locations
France
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
Investigators
Investigator: Frederic Viret, MD Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000564099, IPC-BAYPAN, INCA-RECF0426, IPC-2005-006
Study First Received: October 5, 2007
Last Updated: July 7, 2009
ClinicalTrials.gov Identifier: NCT00541021     History of Changes
Health Authority: Unspecified

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

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
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
Neoplasm Metastasis
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 August 28, 2009