Clinical Trial: Selumetinib and Akt Inhibitor MK2206 or mFOLFOX Therapy Comprising Oxaliplatin and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Previously Treated With Chemotherapy

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

Official Title: Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs mFOLFOX in Patients With Metastatic Pancreatic Cancer After Prior Chemotherapy

Brief Summary: This randomized phase II trial studies how well selumetinib and Akt inhibitor MK2206 work compared to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) therapy in treating patients with metastatic pancreatic cancer previously treated with chemotherapy. Selumetinib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet know whether selumetinib and Akt inhibitor MK2206 are more effective than oxaliplatin and fluorouracil in treating patients with metastatic pancreatic cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess overall survival in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate (selumetinib) and MK-2206 (Akt inhibitor MK2206) compared to those treated with mFOLFOX.

SECONDARY OBJECTIVES:

I. To assess the frequency and severity of toxicity associated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those with mFOLFOX in this patient population.

TERTIARY OBJECTIVES:

I. To assess progression free survival (PFS) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX.

II. To assess objective tumor response in the subset of patients with measurable disease (confirmed and unconfirmed complete and partial response) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX.

III. To bank tissue and blood for future translational medicine studies.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16 (mFOLFOX).

ARM II: Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28.

In all arms, courses rep
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Overall Survival [ Time Frame: Up to 3 years ]

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.


Original Primary Outcome:

  • Overall survival (OS) from date of registration to death due to any cause using the long-rank test, assessed up to 3 years
  • Adverse event profile as assessed by the NCI CTCAE v. 4.0, 28 days


Current Secondary Outcome: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Up to 3 years ]

Only adverse events that are possibly, probably or definitely related to study drug are reported.


Original Secondary Outcome:

  • PFS from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause using the long-rank test, assessed up to 3 years
  • Response using the chi square test, assessed up to 3 years


Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 3, 2012
Date Started: August 2012
Date Completion:
Last Updated: February 10, 2016
Last Verified: July 2015