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Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Progression

Outcome Time Frame:

once all patients completed treatment

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

C-II-004 / 2007-005022-71

NCT ID:

NCT00673504

Start Date:

April 2008

Completion Date:

November 2011

Related Keywords:

  • Pancreatic Cancer
  • cancer
  • pancreatic cancer
  • gemcitabine
  • sunitinib
  • Phase 2
  • Pancreatic Neoplasms

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