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First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00673504•Central European Society for Anticancer Drug Research

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (11)

Städtisches Klinikum Braunschweig

Braunschweig, Germany

Universitätsklinikum Essen

Essen, Germany

Krankenhaus

Frankfurt, Germany

Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin

Frankfurt, Germany

Internistisches Facharztzentrum

Frankfurt, Germany

Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät

Halle, Germany

Facharztpraxis

Heidelberg, Germany

Klinikum Lüdenscheid

Lüdenscheid, Germany

Klinikum Nürnberg Nord

Nuremberg, Germany

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Key Dates

Start Date

April 1, 2008

Primary Completion Date

October 1, 2011

Completion Date

November 1, 2011

Last Updated

December 1, 2011

Enrollment

105

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

Gemcitabine + Sunitinib

DRUG

Gemcitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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