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

Completed · Phase 2

Conditions studied: Pancreatic Acinar Cell Carcinoma, Pancreatic Ductal Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage IV Pancreatic Cancer

In brief

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 facts

Study ID

NCT01658943

Run by

National Cancer Institute (NCI)

People needed

137

Starts

2012-08-01

Expected to finish

2015-06-01

Last updated by the study team

2016-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible
• Patients must have distant metastatic disease; patients with macroscopic residual disease post-resection as the only site of disease are not eligible; patient must not have clinically significant ascites (defined as requiring paracentesis) or have brain metastases
• Patients must have received one line, and no more than one line, of prior gemcitabine-based chemotherapy for advanced/metastatic pancreatic cancer and must have documentation of metastatic disease progression while on this treatment; documented disease progression must occur within 42 days of the last treatment; OR
• For patients who received one line of gemcitabine-based chemotherapy for treatment in the adjuvant setting, recurrence to a metastatic site must be documented by imaging studies within 6 months of completing chemotherapy; chemoradiation as part of adjuvant treatment is acceptable; if the patient received one line of adjuvant gemcitabine-based treatment and had disease recurrence after 6 months of completing chemotherapy, patients will only be eligible after failing one additional line of gemcitabine-based chemotherapy used to treat the metastatic disease
• Patients must have measurable and/or non-measurable disease; x-rays, scans. or physical examinations for assessment of measurable disease must have been completed within 28 days prior to registration; x-rays, scans, or other tests for assessment of non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
• Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered to =< grade 1 from any of the effects of prior therapies or procedures
• Patients must not plan to receive concurrent chemotherapy, radiotherapy, agents known to prolong corrected QT (QTc) interval, or agents known to be strong inducers or inhibitors of cytochrome P450 3A4/5 (CYP3A4/5) or cytochrome P450 1A2 (CYP1A2)
• Patient must not have received prior treatment with fluorouracil, irinotecan, leucovorin calcium, and oxaliplatin (FOLFIRINOX), FOLFOX, oxaliplatin-based chemotherapy, mitogen-activated protein kinase (MEK) inhibitors, phosphoinositide-3-kinase (PI3K) inhibitors, or protein kinase B (AKT) inhibitors
• Zubrod performance status of 0-1
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 9.0 g/dL
• Patients must have adequate kidney function as evidenced by at least ONE of the following:
• Serum creatinine =< 1.5 mg/dL within 14 days prior to registration
• Calculated creatinine clearance >= 60 mL/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
• Total bilirubin =< 1.5 times institutional upper limit of normal(IULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 times IULN
• Patients must have an albumin level >= 3.0 g/dL within 14 days prior to registration
• Patients must have an International Normalized Ratio (INR) =< 1.5 times IULN within 14 days prior to registration
• Patients must have an electrocardiogram (ECG) within 14 days prior to registration; patients must have QTcF (by Fridericia's calculation) =< 450 msec (male) or =< 470 msec (female)
• Patients with baseline neuropathy must be =< grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
• Patients must not have uncontrolled diarrhea or active infection requiring antibiotics and be fully recovered from any previous serious infections within 7 days prior to registration
• Patients must be able to swallow tablets and capsules
• Patients with diabetes must be well controlled with fasting glucose =< grade 1 according to CTCAE v 4.0 within 14 days prior to registration

Where it is running

• The University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills - Peninsula Hospitals — Burlingame, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Epic Care-Dublin — Dublin, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Epic Care Partners in Cancer Care — Emeryville, California, United States
• Kaiser Permanente Hospital — Fontana, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Kaiser Permanente — Fresno, California, United States
• Saint Jude Medical Center — Fullerton, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• The University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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