Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer (PACT-12)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele Reni, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00967603
First received: August 27, 2009
Last updated: January 31, 2012
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • 6-month progression-free survival [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    CT scan


Secondary Outcome Measures:
  • Response rate [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    CT scan

  • Toxicity [ Time Frame: monthly during therapy ] [ Designated as safety issue: Yes ]
    outpatient visit

  • OVERALL SURVIVAL [ Time Frame: monthly ] [ Designated as safety issue: No ]
    outpatient visit

  • PROGRESSION-FREE SURVIVAL [ Time Frame: every 2 months during therapy; every 3 months thereafter ] [ Designated as safety issue: No ]
    CT scan

  • endothelial circulating cells [ Time Frame: baseline + every 2 months during therapy until progression ] [ Designated as safety issue: No ]
  • pharmacogenomics [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • pharmacokynetics [ Time Frame: after 2 months of therapy ] [ Designated as safety issue: No ]
  • pharmacodynamics [ Time Frame: baseline and every 2 months until progression ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: February 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: SUTENT

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967603

Locations
Italy
San Raffaele Scientific Institute
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Michele Reni, MD Istituto Scientifico H. San Raffaele
  More Information

Additional Information:
No publications provided

Responsible Party: Michele Reni, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT00967603     History of Changes
Other Study ID Numbers: CDR0000643632, PACT-12, 2008-000814-65
Study First Received: August 27, 2009
Last Updated: January 31, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014