Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PACT-12  

Official title:

Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967603
• Other study ID #: CDR0000643632
• Secondary ID: PACT-122008-0008
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: January 31, 2012
• Start date: February 2008
• Est. completion date: January 2012

Study information

• Verified date: December 2009
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• sunitinib
oral sunitinib 37.5 mg daily

Locations

Country	Name	City	State
Italy	San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month progression-free survival	CT scan	every 2 months during therapy; every 3 months thereafter	No
Secondary	Response rate	CT scan	every 2 months during therapy; every 3 months thereafter	No
Secondary	Toxicity	outpatient visit	monthly during therapy	Yes
Secondary	OVERALL SURVIVAL	outpatient visit	monthly	No
Secondary	PROGRESSION-FREE SURVIVAL	CT scan	every 2 months during therapy; every 3 months thereafter	No
Secondary	endothelial circulating cells		baseline + every 2 months during therapy until progression	No
Secondary	pharmacogenomics		baseline	No
Secondary	pharmacokynetics		after 2 months of therapy	No
Secondary	pharmacodynamics		baseline and every 2 months until progression	No