Prospective randomized Phase II trial with gemcitabine plus sunitinib versus gemcitabine alone in first-line therapy of metastatic or locally advanced pancreatic cancer
- Conditions
- metastatic or locally advanced pancreatic cancerMedDRA version: 9.1Level: LLTClassification code 10033575Term: Pancreas cancer
- Registration Number
- EUCTR2007-005022-71-DE
- Lead Sponsor
- CESAR Central European Society for Anticancer Drug Research – EWIV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
(1)Adult males and females: over 18 years of age.
(2)Patients who suffer from locally advanced or metastatic pancreatic cancer
(3)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).
(4)ECOG 0 or 1
(5)Signed written informed consent.
(6)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).
(7)Total bilirubin ? 2 x upper limit of normal.
(8)AST and ALT ? 2.5 x upper limit of normal, or ? 5 x upper limit of normal in case of liver metastases.
(9)Serum creatinine ? 1.5 x upper limit of normal
(10)Anticoagulation treatment with heparin or low molecular weight heparin (LMWH): Patients will be allowed to participate provided that close monitoring of at least weekly evaluations are performed.
(11)Normal ECG without QT prolongation (QTc < 450 msec).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
(12)Resectable pancreatic cancer
(13)Previous chemotherapy (for adjuvant or metastatic disease)
(14)Any contraindication for gemcitabine chemotherapy regimen.
(15)Any investigational drug within the 30 days before inclusion.
(16)Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
(17)Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
(18)Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
(19)Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception from the start of treatment up 6 months after end of treatment.
(20)Clinically symptomatic brain or meningeal metastasis. (known or suspected)
(21)Cardiac arrhythmias requiring anti-arhythmics (excluding beta blockers or digoxin).
(22)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
(23)uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ? 3 anti-hypertensive drugs
(24)Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
(25)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].
(26)History of organ allograft
(27)Significant disease which, in the investigator`s opinion would exclude the patient from the study.
(28)Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital)
(29)Patients requiring long-term cortisone therapy
(30)Patients requiring oral anticoagulation treatment (such as marcoumar)
(31)Legal incapacity or limited legal capacity
(32)Known alcohol or drug abuse.
(33)Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
(34)Current fistula formation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate whether the addition of sunitinib to gemcitabine prolongs the progression-free survival (PFS) compared to gemcitabine alone in patients with advanced pancreatic cancer.;Secondary Objective: Secondary objectives are the characterization of additional efficacy outcomes and safety in the experimental arm sunitinib and gemcitabine and their exploratory comparison with the gemcitabine alone arm. Secondary efficacy endpoints are: <br>-objective response (OR)<br>-time-to-progression (TTP)<br>-overall survival (OS)<br>-time-to-treatment-failure (TTF)<br>-safety<br>Secondary safety endpoints are adverse events according to CTC AE v3.0, SAEs.<br>;Primary end point(s): Progression-free-survival (PFS)
- Secondary Outcome Measures
Name Time Method