A multicenter phase II study of G17DT immunogen plus irinotecan in pretreated metastatic colorectal cancer progressing on irinotecan

Cancer Chemotherapy and Pharmacology

Volumn 74, Issue 3, 2014, Pages 479-486

  Rocha Lima, Caio Max ^a   De Queiroz Marques, Eriberto ^a   Bayraktar, Soley ^a   Broome, Paul ^b   Weissman, Charles ^c   Nowacki, Marek ^d   Leslie, Martin ^e   Susnerwala, Shabbir ^f  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b NYOH Latham Cancer Center ^*

^c NYOH Latham Cancer Center   (United States)

^d INSTITUTE OF ONCOLOGY   (Poland)

^e GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^f ROYAL PRESTON HOSPITAL   (United Kingdom)

Author keywords

G17DT; Immunotherapy; Irinotecan; Irinotecan refractory; Metastatic colorectal cancer

Indexed keywords

ALKALINE PHOSPHATASE; ANTIBODY; ANTIGEN; G17DT ANTIGEN; HEMOGLOBIN; IRINOTECAN; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ANTIBODY TITER; ARTICLE; BONE METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER IMMUNOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CONSTIPATION; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ENZYME LINKED IMMUNOSORBENT ASSAY; FATIGUE; FEMALE; FEVER; HEMATOCRIT; HUMAN; HYPOALBUMINEMIA; IMMUNE RESPONSE; INJECTION SITE ABSCESS; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; METASTATIC COLORECTAL CANCER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PLEURA METASTASIS; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SKIN METASTASIS; SOFT TISSUE METASTASIS; SURVIVAL RATE; SURVIVAL TIME; VISCERAL METASTASIS; VOMITING; WEAKNESS;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CANCER VACCINES; COLORECTAL NEOPLASMS; DIARRHEA; DRUG ADMINISTRATION SCHEDULE; FEMALE; GASTRINS; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; NAUSEA; NEUTROPENIA; TREATMENT OUTCOME; VOMITING;

EID: 84907598532     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-014-2520-y     Document Type: Article

References (28)

1. Shike M, Winawer SJ, Greenwald PH, Bloch A, Hill MJ, Swaroop SV (1990) Primary prevention of colorectal cancer. The WHO Collaborating Centre for the Prevention of Colorectal Cancer. Bull World Health Organ 68:377-385
2. American Cancer Society (2013) Cancer facts and figures 2013. Atlanta GACS, 2013. Last Accessed on 15 May 2013
3. Douillard JY, Cunningham D, Roth AD et al (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355:1041-1047 (Pubitemid 30162806)
4. Giacchetti S, Perpoint B, Zidani R et al (2000) Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol 18:136-147 (Pubitemid 30036347)
5. Goldberg RM, Sargent DJ, Morton RF et al (2004) A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol 22:23-30 (Pubitemid 41095110)
6. de Gramont A, Figer A, Seymour M et al (2000) Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol 18:2938-2947 (Pubitemid 30644117)
7. Saltz LB, Cox JV, Blanke C et al (2000) Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343:905-914
8. Fuchs CS, Marshall J, Barrueco J (2008) Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: updated results from the BICC-C study. J Clin Oncol 26:689-690 (Pubitemid 351264373)
9. Cassidy J, Clarke S, Diaz-Rubio E et al (2008) Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol Off J Am Soc Clin Oncol 26:2006-2012
10. Douillard JY, Siena S, Cassidy J et al (2010) Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol Off J Am Soc Clin Oncol 28:4697-4705
11. Van Cutsem EKC, Lang I et al (2011) Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol Off J Am Soc Clin Oncol 29:2011-2019
12. Watson SA, Durrant LG, Crosbie JD, Morris DL (1989) The in vitro growth response of primary human colorectal and gastric cancer cells to gastrin. Int J Cancer 43:692-696 (Pubitemid 19110107)
13. Rehfeld JF, Bardram L, Hilsted L (1989) Gastrin in human bronchogenic carcinomas: constant expression but variable processing of progastrin. Cancer Res 49:2840-2843 (Pubitemid 19148612)
14. Dockray GJ, Varro A, Dimaline R, Wang T (2001) The gastrins: their production and biological activities. Ann Rev Physiol 63:119-139 (Pubitemid 32304314)
15. Seva C, Dickinson CJ, Yamada T (1994) Growth-promoting effects of glycine-extended progastrin. Science 265:410-412 (Pubitemid 24259977)
16. Blackmore M, Doherty E, Manning JE, Hirst BH (1994) Autocrine growth stimulation of human renal Wilms' tumour G401 cells by a gastrin-like peptide. Int J Cancer 57:385-391 (Pubitemid 24168614)
17. Watson SA, Michaeli D, Grimes S et al (1996) Gastrimmune raises antibodies that neutralize amidated and glycine-extended gastrin-17 and inhibit the growth of colon cancer. Cancer Res 56:880-885
18. Watson S, Michaeli D, Morris T (1995) Gastrimmune reduces lung metastases in a human colorectal model. Gut 37:Abstract (A37. 19)
19. Makishima R, Michaeli D, Gaginella TS (1995) Active immunisation against gastrin-17 with an N-terminal derived immunogen inhibits gastric and duodenal lesions in rats. Gastroenterology 4:A824
20. Watson SA, Morris T, Robinson GK et al (1994) Therapeutic effects of anti-gastrin antibodies raised by gastrimmune on a human gastric cancer ascites line MGLVA1 [abstract]. Proc ACR. 436:253
21. Watson SA, Michael D, Justin TA et al (1998) Pre-clinical evaluation of the Gastrimmune immunogen alone and in combination with 5-fluorouracil/ leucovorin in a rat colorectal cancer model. Int J Cancer 75:873-877 (Pubitemid 28134112)
22. Cunningham D, Humblet Y, Siena S et al (2004) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351:337-345 (Pubitemid 38944402)
23. Jonker DJ, O'Callaghan CJ, Karapetis CS et al (2007) Cetuximab for the treatment of colorectal cancer. N Engl J Med 357:2040-2048 (Pubitemid 350106711)
24. Grothey A, Van Cutsem E, Sobrero A et al (2013) Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381:303-312
25. Ajani JA, Hecht JR, Ho L et al (2006) An open-label, multinational, multicenter study of G17DT vaccination combined with cisplatin and 5-fluorouracil in patients with untreated, advanced gastric or gastroesophageal cancer: the GC4 study. Cancer 106:1908-1916 (Pubitemid 43673205)
26. Brett BT, Smith SC, Bouvier CV et al (2002) Phase II study of anti-gastrin-17 antibodies, raised to G17DT, in advanced pancreatic cancer. J Clin Oncol Off J Am Soc Clin Oncol 20:4225-4231 (Pubitemid 35191025)
27. Gou HF, Huang J, Shi HS, Chen XC, Wang YS (2014) Chemoimmunotherapy with oxaliplatin and interleukin-7 inhibits colon cancer metastasis in mice. PLoS ONE 9:e85789
28. Gilliam AD, Broome P, Tpouzov EG et al (2012) An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas 41(3):374-379