Maintenance Therapy With Sunitinib Or Observation In Metastatic Pancreatic Cancer

Study Overview

Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether sunitinib malate is effective as maintenance therapy in delaying tumor progression in patients with metastatic pancreatic cancer who are progression-free after 6 months of induction chemotherapy. PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy to see how well it works compared with observation in avoiding tumor progression after induction chemotherapy in patients with metastatic pancreatic cancer.

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.

Pancreatic Cancer

DRUG: sunitinib

CDR0000643632
PACT-12 (OTHER Identifier) (OTHER: IRCCS San Raffaele)
2008-000814-65 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

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 2009-08-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-01-31
First Submitted that Met QC Criteria 2009-08-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-02-01
First Posted (ESTIMATED) 2009-08-28	Results First Posted N/A	Last Verified 2009-12

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
NO_INTERVENTION: observation no therapy until progression
EXPERIMENTAL: sunitinib sunitinib until progression or for a maximum of 6 months	DRUG: sunitinib oral sunitinib 37.5 mg daily

Participant Group/Arm

Intervention/Treatment

NO_INTERVENTION: observation

no therapy until progression

EXPERIMENTAL: sunitinib

sunitinib until progression or for a maximum of 6 months

DRUG: sunitinib

oral sunitinib 37.5 mg daily

Primary Outcome Measures	Measure Description	Time Frame
6-month progression-free survival	CT scan	every 2 months during therapy; every 3 months thereafter

Secondary Outcome Measures	Measure Description	Time Frame
Response rate	CT scan	every 2 months during therapy; every 3 months thereafter
Toxicity	outpatient visit	monthly during therapy
OVERALL SURVIVAL	outpatient visit	monthly
PROGRESSION-FREE SURVIVAL	CT scan	every 2 months during therapy; every 3 months thereafter
endothelial circulating cells		baseline + every 2 months during therapy until progression
pharmacogenomics		baseline
pharmacokynetics		after 2 months of therapy
pharmacodynamics		baseline and every 2 months until progression

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:

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

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

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Michele Reni, MD, Istituto Scientifico H. San Raffaele

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