Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

NCT ID: NCT00967603

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

observation

no therapy until progression

Group Type: NO_INTERVENTION

No interventions assigned to this group

sunitinib

sunitinib until progression or for a maximum of 6 months

Group Type: EXPERIMENTAL

sunitinib

Intervention Type: DRUG

oral sunitinib 37.5 mg daily

Interventions

sunitinib

oral sunitinib 37.5 mg daily

Intervention Type: DRUG

Other Intervention Names

SUTENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Michele Reni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Reni, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Scientifico H. San Raffaele

Locations

San Raffaele Scientific Institute

Milan, , Italy

Countries

Italy

Other Identifiers

PACT-12

Identifier Type: OTHER

Identifier Source: secondary_id

2008-000814-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000643632

Identifier Type: -

Identifier Source: org_study_id