Clinical Trial: Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Sunitinib Malate (SU11248, NSC #736511, IND #74,019) in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front

Brief Summary: This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the response rate to sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.

SECONDARY OBJECTIVES:

I. To determine the duration of response, progression-free survival and overall survival of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.

II. To determine the safety of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.

OUTLINE: This is a multicenter, nonrandomized study.

Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed every 3 months until 2 years from study entry or until disease progression.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response (CR/PR/stable disease) as measured by RECIST criteria [ Time Frame: At 6 weeks post-initiation of protocol treatment ]

Original Primary Outcome: Response (complete or partial response or stable disease at 6 weeks post-initiation of protocol treatment) as measured by RECIST criteria

Current Secondary Outcome:

  • Response duration [ Time Frame: Up to 2 years ]
    Duration of response will be determined for the subset of patients who achieve a confirmed response of CR or PR. Duration of objective response will be defined as the time from the first tumor assessment indicating response (later confirmed) to the time of disease progression or death from any cause.
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
    Median and 1-year survival will be assessed using Kaplan-Meier methods.
  • Number and percentage of patients reporting common and serious adverse events (AEs), the AEs related to sunitinib, reason for study discontinuation, clinically significant laboratory abnormalities, and AEs with worst NCI CTCAE grade [ Time Frame: Up to 2 years ]
    Summarized descriptively for all patients receiving at least one dose of sunitinib.
  • Overall survival (OS) [ Time Frame: Up to 2 years ]
    Median and 1-year survival will be assessed using Kaplan-Meier methods.


Original Secondary Outcome:

  • Response duration
  • Progression-free survival
  • Toxicity
  • Overall survival


Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 9, 2006
Date Started: November 2006
Date Completion:
Last Updated: June 3, 2013
Last Verified: June 2013