A phase I trial of oblimersen sodium in combination with cisplatin and 5-fluorouracil in patients with advanced esophageal, gastroesophageal junction, and gastric carcinoma

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 33, Issue 1, 2010, Pages 61-65

  Raab, Rachel ^a   Sparano, Joseph A ^a   Ocean, Allyson J ^b   Christos, Paul ^b   Ramirez, Mark ^a   Vinciguerra, Vincent ^c   Kaubisch, Andreas ^a  

^a ALBERT EINSTEIN CANCER CENTER   (United States)

^b WEILL CORNELL MEDICAL CENTER   (United States)

^c NORTH SHORE UNIVERSITY HOSPITAL   (United States)

Author keywords

BCL 2; Gastric cancer; Gastroesophageal cancer; Oblimersen

Indexed keywords

CISPLATIN; DEXAMETHASONE; FLUOROURACIL; GRANULOCYTE COLONY STIMULATING FACTOR; MESSENGER RNA; OBLIMERSEN; PROTEIN BCL 2; SEROTONIN ANTAGONIST;

ADULT; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASCITES; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; DIARRHEA; DIZZINESS; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG TOLERABILITY; DYSPHAGIA; ESOPHAGEAL ADENOCARCINOMA; FATIGUE; FEMALE; HUMAN; HYPERGLYCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPONATREMIA; INFECTION; LOWER ESOPHAGUS SPHINCTER; MALE; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; SENSORY NEUROPATHY; SIDE EFFECT; STOMACH ADENOCARCINOMA; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT DURATION; URETER OBSTRUCTION; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DRUG THERAPY, COMBINATION; ESOPHAGEAL NEOPLASMS; ESOPHAGOGASTRIC JUNCTION; FEMALE; FLUOROURACIL; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; OLIGONUCLEOTIDES, ANTISENSE; PILOT PROJECTS; PROGNOSIS; STOMACH NEOPLASMS; SURVIVAL RATE; THIONUCLEOTIDES; TREATMENT OUTCOME;

EID: 76749168019     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e3181a31ad0     Document Type: Article

References (33)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2007. CA Cancer J Clin. 2007;57:43-66.
2. Fuchs CS, Mayer RJ. Gastric carcinoma. N Engl J Med. 1995;333:32-41.
3. Wagner AD, Grothe W, Haerting J, et al. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006;24:2903-2909.
4. Kaufmann SH, Earnshaw WC. Induction of apoptosis by cancer chemotherapy. Exp Cell Res. 2000;256:42-49.
5. Fesik SW. Promoting apoptosis as a strategy for cancer drug discovery. Nat Rev Cancer. 2005;5:876-885.
6. Kim R, Emi M, Tanabe K, et al. Preclinical evaluation of antisense bcl-2 as a chemosensitizer for patients with gastric carcinoma. Cancer. 2004;101: 2177-2186.
7. Morris MJ, Tong WP, Cordon-Cardo C, et al. Phase I trial of BCL-2 antisense oligonucleotide (G3139) administered by continuous intravenous infusion in patients with advanced cancer. Clin Cancer Res. 2002;8:679-683.
8. Herbst RS, Frankel SR. Oblimersen sodium (Genasense bcl-2 antisense oligonucleotide): a rational therapeutic to enhance apoptosis in therapy of lung cancer. Clin Cancer Res. 2004;10:4245s- 4248s.
9. Klasa RJ, Gillum AM, Klem RE, et al. Oblimersen Bcl-2 antisense: facilitating apoptosis in anticancer treatment. Antisense Nucleic Acid Drug Dev. 2002;12:193-213.
10. Lopes de Menezes DE, Hu Y, et al. Combined treatment of Bcl-2 antisense oligodeoxynucleotides (G3139), p-glycoprotein inhibitor (PSC833), and sterically stabilized liposomal doxorubicin suppresses growth of drug-resistant growth of drug-resistant breast cancer in severely combined immunodeficient mice. J Exp Ther Oncol. 2003;3:72-82.
11. Tauchi T, Sumi M, Nakajima A, et al. BCL-2 antisense oligonucleotide genasense is active against imatinib-resistant BCR-ABL-positive cells. Clin Cancer Res. 2003;9:4267-4273.
12. van de Donk NW, Kamphuis MM, van Dijk M, et al. Chemosensitization of myeloma plasma cells by an antisense-mediated downregulation of Bcl-2 protein. Leukemia. 2003;17:211-219.
13. Tolcher A, Chi K, et al. A Phase II, pharmacokinetic, and biologic correlative study of oblimersen sodium and docetaxel in patients with hormone-refractory prostate cancer. Clin Cancer Res. 2005;11:3854-3861.
14. Marshall J, Chen H, Yang D, et al. A phase I trial of a Bcl-2 antisense (G3139) and weekly docetaxel in patients with advanced breast cancer and other solid tumors. Ann Oncol. 2004;15:1274-1283.
15. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92: 205-216. (Pubitemid 30099779)
16. Glimelius B, Ekstrom K, Hoffman K, et al. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997;8:163-168.
17. Glimelius B, Hoffman K, Haglund U, et al. Initial or delayed chemotherapy with best supportive care in advanced gastric cancer. Ann Oncol. 1994;5: 189-190.
18. Pyrhonen S, Kuitunen T, Nyandoto P, et al. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with nonresectable gastric cancer. Br J Cancer. 1995;71:587-591.
19. Ajani JA, Moiseyenko VM, Tjulandin S, et al.; The V-325 Study Group. Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a phase III trial for advanced gastric or gastroesophageal adenocarcinoma. J Clin Oncol. 2007;25:3210-3216. (Pubitemid 47325603)
20. Ajani JA, Moiseyenko VM, Tjulandin S, et al.; The V-325 Study Group. Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma. J Clin Oncol. 2007;25:3205-3209. (Pubitemid 47333732)
21. Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358:36-46.
22. Boku N, Chin K, Hosokawa K, et al. Biological markers as a predictor for response and prognosis of unresectable gastric cancer patients treated with 5-fluorouracil and cis-platinum. Clin Cancer Res. 1998;4:1469-1474.
23. Reed JC. Mechanisms of apoptosis (Warner/Lambert Award). Am J Pathol. 2000;157:1415-1430.
24. Krajewska M, Kitada S, Winter J, et al. Bcl-B expression in human epithelial and nonepithelial malignancies. Clin Cancer Res. 2008;14:3011-3021.
25. Anderson EM, Miller P, Ilsley D, et al. Gene profiling study of G3139- and Bcl-2-targeting siRNAs identifies a unique G3139 molecular signature. Cancer Gene Ther. 2006;13:406-414.
26. Chi KN, Gleave ME, Klasa R, et al. A phase I dose-finding study of combined treatment with an antisense Bcl-2 oligonucleotide (Genasense) and mitoxantrone in patients with metastatic hormone-refractory prostate cancer. Clin Cancer Res. 2001;7:3920-3927.
27. Mita MM, Ochoa L, Rowinsky EK, et al. A phase I, pharmacokinetic and biologic correlative study of oblimersen sodium (Genasense, G3139) and irinotecan in patients with metastatic colorectal cancer. Ann Oncol. 2006;17: 313-321.
28. Tolcher AW. Preliminary phase I results of G3139 (bcl-2 antisense oligonucleotide) therapy in combination with docetaxel in hormone-refractory prostate cancer. Semin Oncol. 2001;28:67-70.
29. Rudin CM, Kozloff M, Hoffman PC, et al. Phase I study of G3139, a bcl-2 antisense oligonucleotide, combined with carboplatin and etoposide in patients with small-cell lung cancer. J Clin Oncol. 2004;22:1110-1117.
30. Rudin CM, Otterson GA, Mauer AM, et al. A pilot trial of G3139, a bcl-2 antisense oligonucleotide, and paclitaxel in patients with chemorefractory small-cell lung cancer. Ann Oncol. 2002;13:539-545.
31. Rudin CM, Salgia R, Wang X, et al. Randomized phase II Study of carboplatin and etoposide with or without the bcl-2 antisense oligonucleotide oblimersen for extensive-stage small-cell lung cancer: CALGB 30103. J Clin Oncol. 2008;26:870-876.
32. Bedikian AY, Millward M, Pehamberger H, et al.; The Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma. J Clin Oncol. 2006;24:4738-4745.
33. Bedikian AY, Agarwala SS, Gilles E, et al. The AGENDA Study: a randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy- naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538. Abstract T-26.