First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer

November 30, 2011 updated by: Central European Society for Anticancer Drug Research

Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)
Other: B
Gemcitabine
Drug: Gemcitabine
1.000 mg/m2 d1,8,15q4weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Progression
Time Frame: once all patients completed treatment
once all patients completed treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Response Rate (RR)
Time Frame: once all patients completed treatment
once all patients completed treatment
overall survival
Time Frame: at study end
at study end
Safety
Time Frame: at study end
at study end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central European Society for Anticancer Drug Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

December 1, 2011

Last Update Submitted That Met QC Criteria

November 30, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-II-004 / 2007-005022-71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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