First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gemcitabine + Sunitinib
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring cancer, pancreatic cancer, gemcitabine, sunitinib, Phase 2
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)
Sites / Locations
- Städtisches Klinikum Braunschweig
- Universitätsklinikum Essen
- Krankenhaus
- Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
- Internistisches Facharztzentrum
- Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
- Facharztpraxis
- Klinikum Lüdenscheid
- Klinikum Nürnberg Nord
- Robert-Bosch-Krankenhaus
- Kantonsspital St. Gallen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
A
B
Arm Description
Gemcitabine + Sunitinib
Gemcitabine
Outcomes
Primary Outcome Measures
Time to Progression
Secondary Outcome Measures
Response Rate (RR)
overall survival
Safety
Full Information
NCT ID
NCT00673504
First Posted
May 6, 2008
Last Updated
November 30, 2011
Sponsor
Central European Society for Anticancer Drug Research
1. Study Identification
Unique Protocol Identification Number
NCT00673504
Brief Title
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
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Central European Society for Anticancer Drug Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
cancer, pancreatic cancer, gemcitabine, sunitinib, Phase 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Gemcitabine + Sunitinib
Arm Title
B
Arm Type
Other
Arm Description
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Gemcitabine + Sunitinib
Intervention Description
Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1.000 mg/m2 d1,8,15q4weeks
Primary Outcome Measure Information:
Title
Time to Progression
Time Frame
once all patients completed treatment
Secondary Outcome Measure Information:
Title
Response Rate (RR)
Time Frame
once all patients completed treatment
Title
overall survival
Time Frame
at study end
Title
Safety
Time Frame
at study end
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Städtisches Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Krankenhaus
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Internistisches Facharztzentrum
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
City
Halle (Saale)
ZIP/Postal Code
06097
Country
Germany
Facility Name
Facharztpraxis
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Klinikum Lüdenscheid
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Klinikum Nürnberg Nord
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
12. IPD Sharing Statement
Links:
URL
http://www.cesar.or.at/main.asp?VID=1&kat1=49&kat2=370&kat3=&Text=&SSSID=5
Description
German Study Description on CESAR's homepage
Learn more about this trial
First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
We'll reach out to this number within 24 hrs