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

Conditions

• Pancreatic Acinar Cell Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Recurrent Pancreatic Carcinoma
• Stage IV Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Akt Inhibitor MK2206 — DRUG
  Given PO
• Fluorouracil — DRUG
  Given IV
• Oxaliplatin — DRUG
  Given IV
• Selumetinib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Aug 31, 2012

Status verified

Jul 2015

Primary completion

Jun 30, 2015

Completion

Jun 30, 2015

Study Design

Enrollment

137 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (mFOLFOX regimen)
  Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16.
• Experimental: Arm II (Akt inhibitor MK2206 and selumetinib)
  Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28.

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 3 years ]

Locations (534)

Find similar trials in Tucson, AZ

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