First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00673504
Last Updated: 2011-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2008-04-30
2011-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Gemcitabine + Sunitinib
Gemcitabine + Sunitinib
Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
B
Gemcitabine
Gemcitabine
1.000 mg/m2 d1,8,15q4weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine + Sunitinib
Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
Gemcitabine
1.000 mg/m2 d1,8,15q4weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Central European Society for Anticancer Drug Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Non-Profit Otrganization Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
German Study Description on CESAR's homepage
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C-II-004 / 2007-005022-71
Identifier Type: -
Identifier Source: org_study_id