A randomized, double-blind, placebo-controlled, phase II study of oral talactoferrin in combination with carboplatin and paclitaxel in previously untreated locally advanced or metastatic non-small cell lung cancer

Journal of Thoracic Oncology

Volumn 6, Issue 6, 2011, Pages 1098-1103

  Digumarti, Raghunadharao ^a   Wang, Yenyun ^b   Raman, Ganapathi ^c   Doval, Dinesh C ^d   Advani, Suresh H ^e   Julka, Pramod K ^f   Parikh, Purvish M ^g   Patil, Shekhar ^h   Nag, Shona ⁱ   Madhavan, Jayaprakash ^j   Bapna, Ajay ^k   Ranade, Annantbhushan A ^l   Varadhachary, Atul ^b   Malik, Rajesh ^b  

^a NIZAM'S INSTITUTE OF MEDICAL SCIENCES   (India)

^b AGENNIX INC   (United States)

^c CANCER INSTITUTE WIA   (India)

^d RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTRE   (India)

^e JASLOK HOSPITAL AND RESEARCH CENTRE   (India)

^f ALL INDIA INSTITUTE OF MEDICAL SCIENCES   (India)

^g TATA MEMORIAL HOSPITAL   (India)

^h Bangalore Institute of Oncology   (India)

ⁱ JEHANGIR HOSPITAL   (India)

^j GOVERNMENT MEDICAL COLLEGE   (India)

^k Department of Medical and Paediatric Oncology   (India)

^l DEENANATH MANGESHKAR HOSPITAL   (India)

more..

Author keywords

Carboplatin; Lactoferrin; Non small cell lung cancer; Paclitaxel; Talactoferrin

Indexed keywords

CARBOPLATIN; PACLITAXEL; PLACEBO; TALACTOFERRIN;

ADULT; ADVANCED CANCER; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; BONE MARROW TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; GASTROENTERITIS; GASTROINTESTINAL DISEASE; HEMOPTYSIS; HUMAN; HYPESTHESIA; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; METASTASIS; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; THORAX PAIN; THROMBOCYTOPENIA; VOMITING;

EID: 79958111407     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e3182156250     Document Type: Article

References (23)

1. American Cancer Society. Facts and Figures. WHO, 2009, Available at: http://documents.cancer.org/6976.00/6976.00.pdf. Accessed July 20, 2010.
2. Alberti W, Anderson G, Bartolucci A, et al. Chemotherapy in non-small-cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. BMJ 1995;311:899-909.
3. Sun XL, Baker HM, Shewry SC, et al. Structure of recombinant human lactoferrin expressed in Aspergillus awamori. Acta Crystallogr D Biol Crystallogr 1999;55:403-407. (Pubitemid 29083709)
4. Ward PP, Piddington CS, Cunningham G, et al. A system for production of commercial quantities of human lactoferrin: a broad spectrum natural antibiotic. Biotechnology (N Y) 1995;13:498-503.
5. Spadaro M, Caorsi C, Ceruti P, et al. Lactoferrin, a major defense protein of innate immunity, is a novel maturation factor for human dendritic cells. FASEB J 2008;22:2747-2757.
6. de la Rosa G, Yang D, Tewary P, et al. Lactoferrin acts as an alarmin to promote the recruitment and activation of APCs and antigen-specific immune responses. J Immunol 2008;180:6868-6876.
7. Spadaro M, Curcio C, Varadhachary A, et al. Requirement for IFN-7, CD8 + T lymphocytes, and NKT cells in talactoferrin-induced inhibition of neu+ tumors. Cancer Res 2007;67:6425-6432. (Pubitemid 47037527)
8. Varadhachary A, Wolf JS, Petrak K, et al. Oral lactoferrin inhibits growth of established tumors and potentiates conventional chemotherapy. Int J Cancer 2004;111:398-403. (Pubitemid 38998820)
9. Wolf JS, Li G, Varadhachary A, et al. Oral lactoferrin results in T cell-dependent tumor inhibition of head and neck squamous cell carcinoma in vivo. Clin Can Res 2007;13:1601-1610. (Pubitemid 46450453)
10. Mojaverian P. Single and multiple dose safety, tolerability and pharmacokinetics (PK) of oral recombinant lactoferrin (rhLF) in healthy subjects. Presented at the Proceedings of the Annual Meeting of the American Association of Pharmaceutical Scientists, Salt Lake City, Utah, October 26-30, 2003 (abstract).
11. Hayes TG, Falchook GF, Varadhachary GR, et al. Phase I trial of oral talactoferrin alfa in refractory solid tumors. Invest New Drugs 2006;24: 233-240. (Pubitemid 43723899)
12. Hayes TG, Falchook G, Varadhachary A. Phase IB trial of oral talactoferrin in the treatment of patients with metastatic solid tumors. Invest New Drugs 2010;28:156-162.
13. Hayes TG, Varadhachary GR, Falchook G, et al. Oral recombinant human Lactoferrin (rhLF) slows tumor growth in metastatic NSCLC and other advanced incurable cancers: Results of a Phase II study. Proceedings of the American Society of Clinical Oncology 2004; Abstr #3140.
14. 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)
15. Parikh PM, Wang Y, Ranade AA, et al. Oral talactoferrin monotherapy extends survival in patients with refractory NSCLC in a randomized, placebo-controlled Phase II trial. Proceedings of the American Society of Clinical Oncology 2007; Abstr #7540.
16. Jonasch E, Stadler WM, Bukowski RM, et al. Phase II trial of talactoferrin in previously treated patients with metastatic renal cell carcinoma. Cancer 2008;113:72-77. (Pubitemid 351976388)
17. Parikh P, Chang AY, Nag S, et al. Clinical experience with gefitinib in Indian patients. J Thorac Oncol 2008;3:380-385. (Pubitemid 351489478)
18. Artym J, Zimecki M, Kuryszko J, et al. Lactoferrin accelerates reconstitution of the humoral and cellular immune response during chemotherapy-induced immunosuppression and bone marrow transplant in mice. Stem Cells Dev 2005;14:548-555. (Pubitemid 41780806)
19. Dial EJ, Dohrman AJ, Romero JJ, et al. Recombinant human lactoferrin prevents NSAID-induced intestinal bleeding in rodents. J Pharm Pharmacol 2005;57:93-99. (Pubitemid 40030107)
20. Troost FJ, Saris WH, Brummer RJ. Recombinant human lactoferrin ingestion attenuates indomethacin-induced enteropathy in vivo in healthy volunteers. Eur J Clin Nutr 2003;57:1579-1585. (Pubitemid 38016591)
21. Legrand D, Elass E, Carpentier M, et al. Lactoferrin: a modulator of immune and inflammatory responses. Cell Mol Life Sci 2005;62:2549-2559. (Pubitemid 41722207)
22. Hayashida K, Kaneko T, Takeuchi T, et al. Oral administration of lactoferrin inhibits inflammation and nociception in rat adjuvant-induced arthritis. J Vet Med Sci 2004;66:149-154. (Pubitemid 41380329)
23. Hayashida K, Takeuchi T, Shimizu H, et al. Lactoferrin enhances opioid-mediated analgesia via nitric oxide in the rat spinal cord. Am J Physiol Regul Integr Comp Physiol 2003;285:R306-R312. (Pubitemid 36898899)