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India key choice for lung cancer clinical trials by global pharma majors
Nandita Vijay, Bangalore | Friday, December 2, 2011, 08:00 Hrs  [IST]

India has been opted as the hub for lung cancer trials as Swiss pharma major Roche has set up clinical trial sites here as part of its global study for treatment of a particular variant of lung cancer.  Eli Lilly is also engaged in human studies in oncology and is developing a new molecule for lung cancer.

The just concluded observance of lung cancer month in November has brought to light that global pharma cannot ignore India for clinical trials.  The main reason is a vast patient population infected by a type of lung cancer, which is primarily triggered by use of tobacco products,  Dr. Ajay Gupta, Medical Oncologist, MAX Hospital.

According to Dr V. Shantha,  executive chairperson, Cancer Institute, Chennai, 45 per cent of all male cancers could be lung cancer. The incidence has increased from one lakh patients annually a decade ago to 1,57,000 per year.  Lung cancer ranks  third of all cancers and within five years, it could  become a major epidemic among men and could emerge as number one, after breast and cervix cancer, if preventive steps are not taken immediately.

According to Dr. Gupta,  drugs which are prescribed for lung cancer treatment are pemetrexed disodium, bevacizumab, gefitinib, gemcitabine hydrochloride, paclitaxel, docetaxel, vinorelbine, erlotinib hydrochloride and platinum compounds.

The future lies in systemic effective treatments which are yet to evolve. Certain modalities are in evolution which could be  less toxic and  hold some promise in addition to traditional therapies like surgery, radiation and medical chemotherapy.  Targeted therapies  under development are epidermal growth factor receptors with  crizotinib, angiogenesis  with  bevacizumab, antisense, protein kinase C, C-kit, PDGF-r, Cox-2, Ras inhibitors, Raf inhibitors, Map kinase and others like  Tinzaparin (LMWH). This is where India is now becoming an important centre for global lung cancer drug trails, Dr Gupta added.

Among the notable on-going human studies for lung cancer in India according to Dr. Gupta are a clinical trial to compare and study the effect of a new experimental drug AMG 706 or bevacizumab in combination with paclitaxel and carboplatin in patients with advanced non-squamous non-small cell lung cancer is underway and patient recruitment is yet to commence.

Other trials open for patient recruitment are a phase II study for previously untreated subjects with non small cell lung cancer (NSCLC) or Small Cell Lung Cancer (SCLC), a double-blind clinical trial comparing  the study drug and placebo as second line therapy for treatment of locally advanced or metastatic non small cell lung cancer and  cancer vaccine study for unresectable stage III non-small cell lung cancer.

Among the completed trials are: a study of mycobacterium combination with paclitaxel plus cisplatin in advanced NSCLC.  SNX-1012-CLN2; a clinical trial to study the effect of a new drug SNX-1012 on mouth ulcers in patients receiving cancer treatment when compared to a placebo;  a lung cancer study to investigate if adding vandetanib (ZD 6474) to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone in patients with Locally Advanced or Metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC) after failure of first line  anti-cancer therapy; a clinical trial to study the safety and efficacy of ALD518  in patients with non-small cell lung cancer-related fatigue and cachexia; and a study of bavituximab plus paclitaxel and carboplatin in patients with non small cell lung cancer.

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