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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673504
• Other study ID #: C-II-004 / 2007-005022-71
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2008
• Last updated: November 30, 2011
• Start date: April 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Central European Society for Anticancer Drug Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Städtisches Klinikum Braunschweig	Braunschweig
Germany	Universitätsklinikum Essen	Essen
Germany	Internistisches Facharztzentrum	Frankfurt
Germany	Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin	Frankfurt
Germany	Krankenhaus	Frankfurt
Germany	Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät	Halle (Saale)
Germany	Facharztpraxis	Heidelberg
Germany	Klinikum Lüdenscheid	Luedenscheid
Germany	Klinikum Nürnberg Nord	Nürnberg
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Switzerland	Kantonsspital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Central European Society for Anticancer Drug Research

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression		once all patients completed treatment	No
Secondary	Response Rate (RR)		once all patients completed treatment	No
Secondary	overall survival		at study end	No
Secondary	Safety		at study end	Yes

External Links

•   German Study Description on CESAR's homepage