A Phase 2 Randomized, Double-Blind, Multicenter Trial of Imexon Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients with Metastatic Chemotherapy-naïve Pancreatic Adenocarcinoma

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 41, Issue 3, 2018, Pages 230-235

  Cohen, Steven J ^a   Zalupski, Mark M ^b   Conkling, Paul ^c   Nugent, Francis ^d   Ma, Wen Wee ^e   Modiano, Manuel ^f   Pascual, Rolan ^h   Lee, Fa Chyi ⁱ   Wong, Lucas ^j   Hersh, Evan ^g  

^a FOX CHASE CANCER CENTER   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c Virginia Oncology Associates   (United States)

^d LAHEY HOSPITAL AND MEDICAL CENTER   (United States)

^e ROSWELL PARK CANCER INSTITUTE   (United States)

^f Arizona Clinical Research Center   (United States)

^g AmpliMed Corporation   (United States)

^h Northern Indiana Cancer Research Consortium   (United States)

ⁱ UNIVERSITY OF NEW MEXICO   (United States)

^j SCOTT AND WHITE MEMORIAL HOSPITAL   (United States)

more..

Author keywords

gemcitabine; imexon; pancreatic cancer

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CA 19-9 ANTIGEN; CREATININE; GEMCITABINE; HEMOGLOBIN; IMEXON; PLACEBO; 4-IMINO-1,3-DIAZABICYCLO(3.1.0)HEXAN-2-ONE; ALKANONE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ADULT; AGED; ALANINE AMINOTRANSFERASE LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASCITES; ASPARTATE AMINOTRANSFERASE LEVEL; BACKACHE; BILIRUBIN BLOOD LEVEL; BODY WEIGHT DISORDER; BODY WEIGHT LOSS; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CHILL; CONSTIPATION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DEHYDRATION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DYSPNEA; FAINTNESS; FATIGUE; FEMALE; FEVER; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPOALBUMINEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOXIA; INJECTION SITE REACTION; INSOMNIA; INTERNATIONAL NORMALIZED RATIO; KIDNEY FAILURE; LEUKOCYTE COUNT; LIMB PAIN; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MEDIAN SURVIVAL TIME; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; NAUSEA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PANCREAS ADENOCARCINOMA; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PLATELET COUNT; PNEUMONIA; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RIGOR; SENSORY NEUROPATHY; SIDE EFFECT; SWEAT GLAND DISEASE; TASTE DISORDER; THROMBOSIS; VOMITING; ADENOCARCINOMA; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; MIDDLE AGED; MORTALITY; PANCREAS TUMOR; VERY ELDERLY;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; DOUBLE-BLIND METHOD; FEMALE; HEXANONES; HUMANS; MALE; MIDDLE AGED; PANCREATIC NEOPLASMS; PROGRESSION-FREE SURVIVAL;

EID: 84951916217     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0000000000000260     Document Type: Article

References (14)

1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013;63:11-30.
2. Burris HA III, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol. 1997;15:2403-2413.
3. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007;25:1960-1966.
4. Dorr RT, Raymond MA, Landowski TH, et al. Induction of apoptosis and cell cycle arrest by imexon in human pancreatic cancer cell lines. Int J Gastrointest Cancer. 2005;36:15-28.
5. Samulitis BK, Landowski TH, Dorr RT. Inhibition of protein synthesis by imexon reduces HIF-1alpha expression in normoxic and hypoxic pancreatic cancer cells. Invest New Drugs. 2009;27:89-98.
6. Hersh EM, Gschwind CR, Taylor CW, et al. Antiproliferative and antitumor activity of the 2-cyanoaziridine compound imexon on tumor cell lines and fresh tumor cells in vitro. J Natl Cancer Inst. 1992;84:1238-1244.
7. Cohen SJ, Zalupski MM, Modiano MR, et al. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010;66:287-294.
8. Berlin JD, Catalano P, Thomas JP, et al. Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297. J Clin Oncol. 2002;20: 3270-3275.
9. Rocha Lima CM, Green MR, Rotche R, et al. Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate. J Clin Oncol. 2004;22:3776-3783.
10. Poplin E, Feng Y, Berlin J, et al. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: A trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009;27:3778-3785.
11. Moehler TM, Feneberg R, Ho AD, et al. Combined phase I/II study of imexon (AOP99. 0001) for treatment of relapsed or refractory multiple myeloma. Anticancer Drugs. 2010;21:708-715.
12. Weber JS, Samlowski WE, Gonzalez R, et al. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010;116:3683-3691.
13. Samulitis BK, Landowski TH, Dorr RT. Inhibition of protein synthesis by imexon reduces HIF-1alpha expression in normoxic and hypoxic pancreatic cancer cells. Invest New Drugs. 2009; 27:89-98.
14. Sheveleva EV, Landowski TH, Samulitis BK, et al. Imexon induces an oxidative endoplasmic reticulum stress response in pancreatic cancer cells. Mol Cancer Res. 2012;10:392-400.