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First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In 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: NCT00673504
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : December 1, 2011
Sponsor:
Information provided by:
Central European Society for Anticancer Drug Research

Brief Summary:
Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine + Sunitinib Drug: Gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer
Study Start Date : April 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Gemcitabine + Sunitinib
Drug: Gemcitabine + Sunitinib
Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
B
Gemcitabine
Drug: Gemcitabine
1.000 mg/m2 d1,8,15q4weeks



Primary Outcome Measures :
  1. Time to Progression [ Time Frame: once all patients completed treatment ]

Secondary Outcome Measures :
  1. Response Rate (RR) [ Time Frame: once all patients completed treatment ]
  2. overall survival [ Time Frame: at study end ]
  3. Safety [ Time Frame: at study end ]


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

Inclusion Criteria:

  • Patients who suffer from locally advanced or metastatic pancreatic cancer
  • Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
  • ECOG performance status 0 to 1
  • Signed written informed consent.
  • White blood cell count (WBC) >= 3x10^9/L with neutrophils >= 1.5 x 10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 5.6 mmol/L (9 g/dL).
  • Total bilirubin < 2 x upper limit of normal.
  • AST and ALT < 2.5 x upper limit of normal, or < 5 x upper limit of normal in case of liver metastases.
  • Serum creatinine < 1.5 x upper limit of normal
  • Normal ECG without QT prolongation

Exclusion Criteria:

  • Resectable pancreatic cancer
  • Previous chemotherapy (for adjuvant or metastatic disease)
  • Any investigational drug within the 30 days before inclusion.
  • Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
  • Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
  • Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
  • Clinically symptomatic brain or meningeal metastasis. (known or suspected)
  • Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
  • History of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (CHF) > NYHA Class II; cerebrovascular accident or transient ischemic attack; pulmonary embolism
  • Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of up to 3 anti-hypertensive drugs
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
  • Previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1].
  • History of organ allograft
  • Patients requiring long-term cortisone therapy
  • Patients requiring oral anticoagulation treatment (such as marcoumar)

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): NCT00673504


Locations
Germany
Städtisches Klinikum Braunschweig
Braunschweig, Germany, 38114
Universitätsklinikum Essen
Essen, Germany, 45122
Krankenhaus
Frankfurt, Germany, 60488
Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
Frankfurt, Germany, 60590
Internistisches Facharztzentrum
Frankfurt, Germany, 60596
Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
Halle (Saale), Germany, 06097
Facharztpraxis
Heidelberg, Germany, 69115
Klinikum Lüdenscheid
Luedenscheid, Germany, 58515
Klinikum Nürnberg Nord
Nürnberg, Germany, 90419
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Central European Society for Anticancer Drug Research

Additional Information:
Responsible Party: Central European Society for Anticancer Drug Research-EWIV, Non-Profit Otrganization Oncology
ClinicalTrials.gov Identifier: NCT00673504     History of Changes
Other Study ID Numbers: C-II-004 / 2007-005022-71
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: November 2011

Keywords provided by Central European Society for Anticancer Drug Research:
cancer
pancreatic cancer
gemcitabine
sunitinib
Phase 2

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
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors