Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: sunitinib

• Registration Number: NCT00967603
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Status Verified: 2009-12
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sunitinib	sunitinib	sunitinib until progression or for a maximum of 6 months

Primary Outcome Measures

Name	Time	Method
6-month progression-free survival	every 2 months during therapy; every 3 months thereafter	CT scan

Secondary Outcome Measures

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

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milan, Italy