Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00541021
First received: October 5, 2007
Last updated: December 13, 2009
Last verified: July 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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.

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
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00541021     History of Changes
Other Study ID Numbers: CDR0000564099, IPC-BAYPAN, INCA-RECF0426, IPC-2005-006
Study First Received: October 5, 2007
Last Updated: December 13, 2009
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

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

ClinicalTrials.gov processed this record on July 29, 2014