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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
sunitinib
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Raffaele Scientific Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

observation

sunitinib

Arm Description

no therapy until progression

sunitinib until progression or for a maximum of 6 months

Outcomes

Primary Outcome Measures

6-month progression-free survival
CT scan

Secondary Outcome Measures

Response rate
CT scan
Toxicity
outpatient visit
OVERALL SURVIVAL
outpatient visit
PROGRESSION-FREE SURVIVAL
CT scan
endothelial circulating cells
pharmacogenomics
pharmacokynetics
pharmacodynamics

Full Information

First Posted
August 27, 2009
Last Updated
January 31, 2012
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT00967603
Brief Title
Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer
Acronym
PACT-12
Official Title
Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
observation
Arm Type
No Intervention
Arm Description
no therapy until progression
Arm Title
sunitinib
Arm Type
Experimental
Arm Description
sunitinib until progression or for a maximum of 6 months
Intervention Type
Drug
Intervention Name(s)
sunitinib
Other Intervention Name(s)
SUTENT
Intervention Description
oral sunitinib 37.5 mg daily
Primary Outcome Measure Information:
Title
6-month progression-free survival
Description
CT scan
Time Frame
every 2 months during therapy; every 3 months thereafter
Secondary Outcome Measure Information:
Title
Response rate
Description
CT scan
Time Frame
every 2 months during therapy; every 3 months thereafter
Title
Toxicity
Description
outpatient visit
Time Frame
monthly during therapy
Title
OVERALL SURVIVAL
Description
outpatient visit
Time Frame
monthly
Title
PROGRESSION-FREE SURVIVAL
Description
CT scan
Time Frame
every 2 months during therapy; every 3 months thereafter
Title
endothelial circulating cells
Time Frame
baseline + every 2 months during therapy until progression
Title
pharmacogenomics
Time Frame
baseline
Title
pharmacokynetics
Time Frame
after 2 months of therapy
Title
pharmacodynamics
Time Frame
baseline and every 2 months until progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Organizational Affiliation
Istituto Scientifico H. San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Scientific Institute
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

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Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

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