Two doses of NGR-hTNF in combination with capecitabine plus oxaliplatin in colorectal cancer patients failing standard therapies

Annals of Oncology

Volumn 22, Issue 4, 2011, Pages 973-978

  Mammoliti, S ^a   Andretta, V ^a   Bennicelli, E ^a   Caprioni, F ^a   Comandini, D ^a   Fornarini, G ^a   Guglielmi, A ^a   Pessino, A ^a   Sciallero, S ^a   Sobrero, A F ^a   Mazzola, G ^b   Lambiase, A ^b   Bordignon, C ^b,c  

^a UNIVERSITY OF GENOA   (Italy)

^b Clinical Development Consultant   (Italy)

^c VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

Author keywords

Colorectal cancer; NGR hTNF; Vascular targeting agent

Indexed keywords

ANTINEOPLASTIC AGENT; ASPARAGINYLGLYCYLARGININE RECOMBINANT TUMOR NECROSIS FACTOR; CAPECITABINE; OXALIPLATIN; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ANXIETY DISORDER; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHILL; CLINICAL ARTICLE; CLINICAL ASSESSMENT; COLORECTAL CANCER; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DUODENOGASTRIC REFLUX; FATIGUE; FEMALE; HICCUP; HUMAN; HYPERGLYCEMIA; HYPERSENSITIVITY; HYPERTENSION; HYPERURICEMIA; LOW DRUG DOSE; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NAUSEA; PAIN; PARESTHESIA; PERIPHERAL EDEMA; PRESYNCOPE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

EID: 79953329168     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq436     Document Type: Article

References (16)

1. Chau I, Cunningham D. Treatment in advanced colorectal cancer: what, when and how? Br J Cancer 2009; 100: 1704-1719.
2. Sobrero A, Bruzzi P. Incremental advance or seismic shift? The need to raise the bar of efficacy for drug approval. J Clin Oncol 2009; 27: 5868-5873.
3. Curnis F, Sacchi A, Borgna L et al. Enhancement of tumor necrosis factor alpha antitumor immunotherapeutic properties by targeted delivery to aminopeptidase N (CD13). Nat Biotechnol 2000; 18: 1185-1190.
4. Corti A, Ponzoni M. Tumor vascular targeting with tumor necrosis factor alpha and chemotherapeutic drugs. Ann N Y Acad Sci 2004; 1028: 104-112.
5. Curnis F, Arrigoni G, Sacchi A et al. Differential binding of drugs containing the NGR motif to CD13 isoforms in tumor vessels, epithelia, and myeloid cells. Cancer Res 2002; 62: 867-874.
6. Rangel R, Sun Y, Guzman-Rojas L et al. Impaired angiogenesis in aminopeptidase N-null mice. Proc Natl Acad Sci U S A 2007; 104(11): 4588-4593.
7. van Laarhoven HWM, Fiedler W, Desar IME et al. Phase I clinical and magnetic resonance imaging study of the vascular agent NGR-hTNF in patients with advanced cancers (European Organization for Research and Treatment of Cancer Study 16041). Clin Cancer Res 2010; 16: 1315-1323.
8. Gregorc V, Citterio C, Vitali G et al. Defining the optimal biological dose of NGRhTNF, a selective vascular targeting agent, in advanced solid tumours. Eur J Cancer 2010; 46: 198-206.
9. Rimassa L, Sobrero AF, Santoro A et al. Phase II study of NGR-hTNF, a selective vascular targeting agent, administered as single agent in patients with colorectal cancer refractory to standard regimens. J Clin Oncol 2009; 27 (Suppl): 15s (abstr 4088).
10. Curnis F, Sacchi A, Corti A. Improving chemotherapeutic drug penetration in tumors by vascular targeting and barrier alteration. J Clin Invest 2002; 110: 475-482.
11. Sacchi A, Gasparri A, Gallo-Stampino C et al. Synergistic antitumor activity of cisplatin, paclitaxel, and gemcitabine with tumor vasculature-targeted tumor necrosis factor-alpha. Clin Cancer Res 2006; 12: 175-182.
12. Gregorc V, Santoro A, Bennicelli E et al. Phase Ib study of NGR-hTNF, a selective vascular targeting agent, administered at low doses in combination with doxorubicin to patients with advanced solid tumours. Br J Cancer 2009; 101: 219-224.
13. De Braud FG, Gregorc V, De Pas TM. A phase I study to define the optimal low dose of NGR-hTNF, a novel vascular targeting agent (VTA), in combination with cisplatin in patients (pts) with solid tumors. J Clin Oncol 2008; 26 (Suppl): (abstr 14647).
14. Von Hoff DD. There are no bad anticancer agents, only bad clinical trial designs. Twenty-first Richard and Hinda Rosenthal Foundation Award Lecture. Clin Cancer Res 1998; 4: 1079-1086.
15. Mick R, Crowley JJ, Carroll RJ. Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint. Control Clin Trials 2000; 21: 343-359.
16. Aderka D, Sorkine P, Abu-Abid S. Shedding kinetics of soluble tumor necrosis factor (TNF) receptors after systemic TNF leaking during isolated limb perfusion. J Clin Invest 1998; 101: 650-659.