Clinical trial NCT00673504: First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: cancer
pancreatic cancer
gemcitabine
sunitinib
Phase 2
Lead sponsor: Central European Society for Anticancer Drug Research
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Time to Progression
timeFrame: once all patients completed treatment
Secondary outcomes:
measure: Response Rate (RR)
timeFrame: once all patients completed treatment
measure: overall survival
timeFrame: at study end
measure: Safety
timeFrame: at study end
Other outcomes:
Locations:
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Krankenhaus
city: Frankfurt
country: Germany
facility: Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
city: Frankfurt
country: Germany
facility: Internistisches Facharztzentrum
city: Halle (Saale)
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
city: Heidelberg
country: Germany
facility: Facharztpraxis
city: Luedenscheid
country: Germany
facility: Klinikum Lüdenscheid
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
References: