Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
OBJECTIVES:
- Compare the 6-month progression-free survival of patients with metastatic pancreatic
cancer without progression after 6 months of induction chemotherapy treated with
sunitinib malate as maintenance therapy vs observation.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive oral sunitinib malate once daily for up to 6 months in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Pathologically confirmed metastatic pancreatic adenocarcinoma
- Stage IV disease
- Received chemotherapy for a duration of 6 months
- No progressive disease for ≥ 6 months since beginning of induction chemotherapy
(irrespective of regimen and response: stable disease, partial response, or complete
response) demonstrated by the following:
- Two consecutive CT or MR scans separated by ≥ 6 weeks
- Normal or no CA19.9 increase > 20% during the last month
PATIENT CHARACTERISTICS:
- Karnofsky Performance Status 50-100%
- Adequate bone marrow, liver, and kidney function
- Normal thyroid gland function (euthyroid)
- Not pregnant or nursing
- No duodenal, gastric, or intestinal infiltration
- Able to take oral medication
- None of the following conditions related to cardiac disease, failure, or vascular
disease including any of the following:
- QTc interval prolongation
- Congestive heart failure
- Serious cardiac arrhythmias
- Active coronary artery disease
- Myocardial infarction
- Ischemia
- Cerebrovascular accident
- Evidence of pre-existing uncontrolled hypertension
- No other malignancies except surgically cured carcinoma in situ of the cervix, basal
or squamous cell carcinoma of the skin, or other adequately treated neoplasms for
which the patient has been disease-free for ≥ 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other prior chemotherapy apart from first-line treatment for pancreatic cancer
- More than 3 weeks and less than 8 weeks since prior chemotherapy (> 1 week in the
case of fluorouracil as continuous infusion or capecitabine)
- No prior antiangiogenesis drugs, including any of the following:
- Sunitinib malate
- Sorafenib
- Bevacizumab
- AZD2171
- Vatalanib
- VEGF trap
- Pazopanib
- More than 1 month since prior major surgical procedure and completely recovered
- More than 7-12 days since prior and no concurrent drugs that are known CYP3A4
inhibitors
- No concurrent drugs with potential anti-arrhythmic activity
- No concurrent thrombolytic agent at therapeutical dose
- No concurrent treatment with other experimental drugs
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
6-month progression-free survival
Outcome Description:
CT scan
Outcome Time Frame:
every 2 months during therapy; every 3 months thereafter
Safety Issue:
No
Principal Investigator
Michele Reni, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Istituto Scientifico H. San Raffaele
Authority:
Italy: Ministry of Health
Study ID:
CDR0000643632
NCT ID:
NCT00967603
Start Date:
February 2008
Completion Date:
January 2012
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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