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

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Gemcitabine + Sunitinib
DRUG: Gemcitabine

C-II-004 / 2007-005022-71

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-05-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-11-30
First Submitted that Met QC Criteria 2008-05-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-12-01
First Posted (ESTIMATED) 2008-05-07	Results First Posted N/A	Last Verified 2011-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: A Gemcitabine + Sunitinib	DRUG: Gemcitabine + Sunitinib Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
OTHER: B Gemcitabine	DRUG: Gemcitabine 1.000 mg/m2 d1,8,15q4weeks

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: A

Gemcitabine + Sunitinib

DRUG: Gemcitabine + Sunitinib

Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)

OTHER: B

Gemcitabine

DRUG: Gemcitabine

1.000 mg/m2 d1,8,15q4weeks

Primary Outcome Measures	Measure Description	Time Frame
Time to Progression		once all patients completed treatment

Secondary Outcome Measures	Measure Description	Time Frame
Response Rate (RR)		once all patients completed treatment
overall survival		at study end
Safety		at study end

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record