Safety and pharmacokinetic study of RPI.4610 (ANGIOZYME), an anti-VEGFR-1 ribozyme, in combination with carboplatin and paclitaxel in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 56, Issue 4, 2005, Pages 329-336

  Kobayashi, Hiroyuki ^a   Eckhardt, S Gail ^b   Lockridge, Jennifer A ^c   Rothenberg, Mace L ^a   Sandler, Alan B ^a   O'Bryant, Cindy L ^b   Cooper, Wendy ^a   Holden, Scott N ^b   Aitchison, Roger D ^c   Usman, Nassim ^c   Wolin, Maurice ^d   Basche, Michele L ^b  

^a VANDERBILT INGRAM CANCER CENTER   (United States)

^b UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^c Sirna Therapeutics Inc   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Angiogenesis inhibitors; ANGIOZYME; Carboplatin; Paclitaxel; Pharmacokinetics; Ribozyme; Vascular endothelial growth factor receptor

Indexed keywords

ANGIOZYME; ANTIEMETIC AGENT; CARBOPLATIN; CIMETIDINE; CISPLATIN; DIPHENHYDRAMINE; FLUOROURACIL; PACLITAXEL; RIBOZYME; RPI 4610; VASCULOTROPIN INHIBITOR; VASCULOTROPIN RECEPTOR 1;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BLADDER CANCER; BLEEDING; BRAIN HEMORRHAGE; BRONCHITIS; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG SAFETY; DYSPNEA; ESOPHAGUS CANCER; FATIGUE; FEMALE; HEART ATRIUM FIBRILLATION; HUMAN; HYPOXIA; LYMPHEDEMA; MALE; MYALGIA; NAUSEA AND VOMITING; NEUTROPENIA; PAIN; PERIPHERAL NEUROPATHY; PNEUMONIA; PRIORITY JOURNAL; RASH; SOLID TUMOR; SOMNOLENCE; STOMATITIS; SYNCOPE; THROMBOCYTOPENIA; THROMBOEMBOLISM; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VISUAL IMPAIRMENT;

ADULT; AGED; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CARBOPLATIN; DRUG INTERACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PACLITAXEL; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; RNA, CATALYTIC;

EID: 23244448047     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-004-0968-x     Document Type: Article

References (21)

1. Adjei AA, Dy GK, Erlichman C et al (2003) A phase I trial of ISIS 2503, an antisense inhibitor of H-ras, in combination with gemcitabine in patients with advanced cancer. Clin Cancer Res 9:115-123
2. Akerley W, Herndon JE, Egorin MJ et al (2003) Weekly, high-dose paclitaxel in advanced lung carcinoma: a phase II study with pharmacokinetics by the Cancer and Leukemia Group B. Cancer 97:2480-2486
3. Allain P, Berre S, Mauras Y, Le Bouil A (1992) Evaluation of inductively coupled mass spectrometry for the determination of platinum in plasma. Biol Mass Spectrom 21:141-143
4. Bamberger ES, Perrett CW (2002) Angiogenesis in epithelian ovarian cancer. Mol Pathol 55:348-359
5. Bauer J, Morrison B, Oates R et al (2003) ANGIOZYME and interferon-α2b synergistically inhibit tumor angiogenesis. Proc Am Assoc Cancer Res 44 (Abstr 1159)
6. Buoen C, Holm S, Thomsen MS (2003) Evaluation of the cohort size in phase I dose escalation trials based on laboratory data. J Clin Pharmacol 43:470-476
7. Herbst RS, Takeuchi H, Teicher BA (1998) Paclitaxel/carboplatin administration along with antiangiogenic therapy in non-small-cell lung and breast carcinoma models. Cancer Chemother Pharmacol 41:497-504
8. Hurwitz H, Fehrenbacher L, Novotny W et al (2004) Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342
9. Jackson E, Sweedler D, Hartsough K et al (2002) Assessment of pharmacokinetic drug interactions between carboplatin and ANGIOZYME in vivo. Proc Am Assoc Cancer Res 43 (Abstr 1927)
10. Margolin K, Gordon MS, Holmgren E et al (2001) Phase Ib trial of intravenous recombinant humanized monoclonal antibody to vascular endothelial growth factor in combination with chemotherapy in patients with advanced cancer: pharmacologic and long-term safety data. J Clin Oncol 19:851-856
11. Meert AP, Paesmans M, Martin B et al (2002) The role of microvessel density on the survival of patients with lung cancer: a systematic review of the literature with meta-analysis. Br J Cancer 87:694-701
12. Parry TJ, Cushman C, Gallegos AM et al (1999) Bioactivity of anti-angiogenic ribozymes targeting Flt-1 and KDR mRNA. Nucleic Acids Res 27:2569-2577
13. Pavco PA, Bouhana KS, Gallegos AM et al (2000) Antitumor and antimetastatic activity of ribozymes targeting the messenger RNA of vascular endothelial growth factor receptors. Clin Cancer Res 6:2094-2103
14. Pivot X, Cals L, Cupissol D et al (2001) Phase II trial of a paclitaxel-carboplatin combination in recurrent squamous cell carcinoma of the head and neck. Oncology 60:66-71
15. Royer I, Alvinerie P, Armand JP et al (1995) Paclitaxel metabolites in human plasma and urine: identification of 6 alpha-hydroxytaxol, 7-epitaxol and taxol hydrolysis products using liquid chromatography/atmospheric-pressure chemical ionization mass spectrometry. Rapid Commun Mass Spectrom 9:495-502
16. Rudin CM, Kozloff M, Hoffman PC et al (2004) 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 22:1110-1117
17. Sandberg JA, Parker VP, Blanchard KS et al (2000) Pharmacokinetics and tolerability of an antiangiogenic ribozyme (ANGIOZYME) in healthy volunteers. J Clin Pharmacol 40:1462-1469
18. Sandberg JA, Sproul CD, Blanchard KS et al (2000) Acute toxicology and pharmacokinetic assessment of a ribozyme (ANGIOZYME) targeting vascular endothelial growth factor receptor mRNA in the cynomolgus monkey. Antisense Nucleic Acid Drug Dev 10:153-162
19. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologies Evaluation and Research (1999) In vivo drug metabolism/drug interaction studies - study design, data analysis, and recommendations for dosing and labeling
20. Venook A, Hurwitz H, Cunningham C et al (2003) Relationship of clinical outcome in metastatic colorectal carcinoma to levels of soluble VEGFR-1: results of a phase II trial of a ribozyme targeting the pre-mRNA of VEGFR-1 (angiozyme) in combination with chemotherapy. Proc Am Soc Clin Oncol 22 (Abstr 1025)
21. Weng DE, Weiss P, Kellackey C et al (2001) Angiozyme pharmacokinetic and safety results: a phase I/II study in patients with refractory solid tumors. Proc Am Soc Clin Oncol 20 (Abstr 393)