Neeman Presentation on Oncology

8/14/2019 Neeman Presentation on Oncology

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NEEMAN MEDICAL INTERNATIONAL

PRESENTATION

ON

THERAPEUTIC AREA: ONCOLOGY


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Neeman experience with Oncology trials:

Neeman medical has an experience of conducting 14 clinical trials in the field of

Oncology. Some of the studies are on going and some of them have been successfully

completed.

The List of Oncology studies are:

ProjectNo

Indication Company Phase Status

1 Adenocarcinoma Dabur I Complete

2 Ca Breast GSK II Complete

3 Bowel Dysfunction in Ca patients GSK II b Complete

4 Ca Pancreas Threshold III Complete5 Head & Neck Cancer GSK II Ongoing

6 Renal Cell Carcinoma GSK III Complete

7 Ca Breast GSK III Ongoing

8 Ca Breast GSK II Ongoing

9 Metastatic Ca Breast GSK III Ongoing

10 Head & Neck Cancer GSK II Ongoing

11 Advanced Cancer Onconova I Ongoing

12Carcinoma induced Nausea

& VomitingGSK III Ongoing

13 Ca breast GSK III Ongoing

14 Cancer Pancreas Globeimmune II Ongoing15 CINV AP Pharma III Ongoing

Neemans experience with conducting clinical trials in other therapeutic areas:

0 5 10 15 20 25

Oncology

Psychiatry/Neurology

Others

Endocrinology/Metabolic Disorder

dermatology

Ophthalmology

Cardiology

Gastr oenter ology

Infec ti ous Dieases

HIV

Respirator y Diseases

Vaccine

Rheumatology/Orthopedic

Kidney Transplant/ Immunology

Devices

TherapeuticArea

Number of Studies


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PATIENT LOAD and STANDARD OF CARE FOR DIFFERENT INDICATIONS:

Head and Neck Carcinoma:

Therapeutic Area: Oncology

Indication: Head and Neck Carcinoma

Patient load site wiseSite Type of Hospital Patient Load/ year

Site 1 Public 200

Site 2 Public 650

Site 3 Private 180

Site 4 Private 200

Site 5 Public 50-75

Standard of Care:

Early detection and treatment by multiple modalities is important for better

prognosis in head and neck cancer.

Nearly all patients with advanced disease require adjuvant radiotherapy,

preoperatively or postoperatively.

Administration of chemotherapeutics in treating head and neck cancers is being

actively pursued

Surgical resection remains the criterion standard for treatment of head and neck

cancer


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Breast carcinoma:


Indication: Breast cancer

Patient load site wise

Site Type of Hospital Patient Load/ year

Site 1 Public 417

Site 2 Public 150

Site 3 Private 400

Site 4 Private 12

Site 5 Public 10

Standard of care:

Treatment may be curative or palliative.

Curative treatment is advised for clinical stages-I, II, & III disease.

Patients with locally advanced (T3, T4) and even inflammatory tumors may be

cured with multi-modality therapy, but in most palliation is all that can be

expected.

Modified radical mastectomy has been the standard therapy for most patients

with breast cancer

Radiotherapy

Following surgery and radiation therapy, chemotherapy or hormonal therapy is

advocated for most patients with curable breast cancer.


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Non-small cell Lung Carcinoma:


Indication: Non small cell lung cancer


Site Type of Hospital Patient Load/year

Site 1 Public 30

Site 2 Public 20

Site 3 Private 10

Site 4 Private 15

Site 5 Public 5

Standard of care:

Surgical resection where possible

Late stages treated with multimodality approach, including chemotherapy

and radiotherapy

i. Neoadjuvant chemotherapy - antineoplastic drugs in advance of

surgery or radiation therapy

ii. Adjuvant chemotherapy consists of administering antineoplastic

drugs following surgery or radiation therapy


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Bone Metastases associated with solid tumors:


Indication: Bone metastases associated with solid tumors


Site Type of Hospital Patient Load/ year

Site 1 Public 25

Site 2 Public 12-15

Site 3 Private 8

Site 4 Private 40-50

Site 5 Public 10

Standard of care:

Chemotherapy

Radiotherapy

Immunotherapy


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Colorectal Carcinoma:


Indication: Colorectal Ca



Site 1 Public 3

Site 2 Public 2

Site 3 Private 1

Site 4 Private 5

Site 5 Public 2

Standard of care:

Resection of the primary colonic or rectal cancer is the treatment of choice for

almost all patients who have resectable lesions

Adjuvant chemotherapy and radiotherapy have been demonstrated to improve

overall and tumor-free survival in selected patients with colon cancer.


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Cervical Intraepithelial Neoplasia:


Indication: CIN



Site 1 Public 200

Site 2 Public 250


Site 4 Private 100

Site 5 Public 200

Standard of Care:

Preventive measures include regular cytologic screening to detect abnormalities,

limiting the number of sexual partners, using a diaphragm or condom for coitus,and stopping smoking or exposure to second-hand smoke.

Treatment:

o CAUTERIZATION OR CRYOSURGERY

o CO2 LASER

o LOOP RESECTION

o CONIZATION OF THE CERVIX

FOLLOW-UP: Because recurrence is possiblefollow-up is imperative.


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Thyroid Carcinoma:


Indication: Thyroid Carcinoma



Site 1 Public 50

Site 2 Public 30


Site 4 Private 60

Site 5 Public 20

Standard of Care:

Surgical removal is the treatment of choice for thyroid carcinomas

Patients who have had a thyroidectomy must take thyroid hormone replacement

for life.

Thyroid carcinomas are extraordinarily resistant to chemotherapy

In patients with visible RAI uptake and those with stage IIIV cancer should be

treated with adjuvant 131I therapy, when possible


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Prostate Ca study:


Indication: Prostate Cancer

Site Type of Hospital Number of Patient

Site 1 Public 6

Site 2 Public 4

Site 3 Private 3

Site 4 Private 1 to 2

Site 5 Public 5 to 6

Standard of Care:

Treatment decisions are at present made on the basis of tumor grade and stage and the

age and health of the patient.

Both radiation therapy and radical prostatectomy allow for acceptable levels of local

control

RADICAL PROSTATECTOMY: In radical prostatectomy, the seminal vesicles,

prostate, and ampullae of the vas deferens are removed. Refinements in

technique have allowed maintenance of urinary continence in most patients and

erectile function in selected patients

RADIATION THERAPY: Radiation can be delivered by a variety of techniques

including use of external beam radiotherapy and transperineal implantation of

radioisotopes

LOCALLY AND REGIONALLY ADVANCED DISEASE:

Those with locally extensive cancers, including those with seminal vesicle and

bladder neck invasion, are at increased risk of both local and distant relapse

despite conventional therapy.


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Currently, a variety of investigational regimens are being tested in an effort to

improve local and distant relapse rates in such patients.

Combination therapy (androgen deprivation combined with surgery or irradiation),

newer forms of irradiation, and hormonal therapy alone are being tested in such

patients.

Neoadjuvant androgen deprivation therapy combined with external beam

radiation therapy has demonstrated improved survival

METASTATIC DISEASE

Androgen deprivation may be induced at several levels along the pituitarygonadal axis

using a variety of methods or agents

Use of LHRH agonists (leuprolide, goserelin)drugs delivered in monthly or 3-

monthly depothas allowed induction of androgen deprivation without

orchiectomy or administration of diethylstilbestrol.

Administration of LHRH agonists and orchiectomy are the most common forms of

primary androgen blockade used.

ketoconazole should be considered in patients with advanced prostatic cancer

who present with spinal cord compression, bilateral ureteral obstruction, or

disseminated intravascular coagulation.

Complete androgen blockade can be achieved by combining an antiandrogen

with use of an LHRH agonist or orchiectomy

Bisphosphonates are increasingly being used with metastatic bone disease.


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Hospitals:


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CURRICULUM VITAE

Dinesh Chandra Doval

Senior consultant & Chief

Department of Medical oncology

Rajiv Gandhi Cancer Institute

Research Centre

Sector V

Rohini

Delhi 110085

EDUCATIONAL QUALIFICATION: : MBBS, MD

Training pertaining to Speciality: (Oncology)

Medical Oncology at Tata Memorial Hospital , Bombay (1981-1982)

U.I.C.C. Post Graduate course in Clinical Career Chemotherapy, Madras (Dec

1983)

Certificate course in Genetic Engineering, Indian Institute of Science, Bangalore

(1988).

MEMBERSHIP OF PROFESSIONAL & SCIENTIFIC BODIES: 9

RESEARCH

Consistent record of clinical research having participated more than 30 international &

national studies.

Pioneered by doing the first phase I study in India.

Have taken up anticancer drug development in India being associated with a 2nd

phase I study from India.

Conducted efficacy & safety study for two of the indigenously developed growth

factors in India.


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Have taken up one of the important regional problem of North India carcinoma

gall baldder.

RECENTLY COMPLETED STUDIES

1. A stratified phase II trial of Docetaxel 100 or 75mg / sqm as a second line

chemotherapy in patients with metastatic breast cancer who have failed a prior

treatment with anthracycline (Principal Investigator).

2. A multicentre , randomized , double blind study of Idoxfene 40mg / day

Tamoxifen 20mg/ day as first line hormonal therapy in metastatic breast cancer

in postmenopausal women (Principal Investigator).

3. A randomized phase III study of Gemcitabine Vs Epirubicin in patients with

metastatic Breast Cancers (Principal Investigator)..

4. A randomized phase II trial evaluating different schedules of CPT 11 combined

with infusional or bolus 5 FU/ 5 FA a front line therapy for advanced colorectal

cancers. (Principal Investigator).

5. A multi center randomized phase II trial of Taxotere combined with cisplatinum or

5 FU in patients with unresectable locally advanced squamous cell carcinoma of

the head & head. (Principal Investigator).

6. A phase II study of Gemcitabine plus cisplatin in chemotherapy naveunresectable hepatocellular carcinoma (Principal Investigator).

7. Multicenter study of Cremaphor free protein stabilised Nanoparticle formulation of

Paclitaxel (ABI 007) in patients with stage IV metastatic breast cancer. (High

dose study protocol CA 002 O ). (Principal Investigator).


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8. Multicenter study of Cremaphor free protein stabilized Nanoparticle formulation of

Paclitaxel (ABI 007) in metastatic breast cancer. ( Low dose study protocol CA

002 OLD ). (Principal Investigator).

9. Phase II study of Gemcite & Cisplatin in unresectable carcinoma gall bladder.

(Principal Investigator).

10. Efficacy & safety of G-CSF (DRL ) in prevention of Chemotherapy induced

neutropenia in cancer patients. (Principal Investigator).

11. Phase 3 Randomized Double blind Evaluation of LY 353381 Compared with

Tamoxifen in Women with locally advanced or Metastatic Breast Cancer. (Co-

Investigator).

12. LY333328 Dose finding in subjects with S aureus Bacteremia (Phase II trial).

(Co- Investigator).

13. A randomized Phase III study comparing Gemcitabline plus Carboplatin V/s .

Carboplatin Monotherapy in Advanced Epithelial Ovarian Carcinoma who failed

first line platinum based therapy . (Principal Investigator).

14. A Phase III Trial of ALIMTA v/s Docetaxel in patients with locally advanced or

Metastatic Non- small cell lung cancer (NSCLC)who were previously treated with

Chemotherapy. (Principal Investigator).

15. Randomized Phase II-III study in first line hormonal treatment for Metastatic

breast cancer with Examestane or Tamoxifen. (Principal Investigator).

16. Phase I Clinical trial on DRF 7295 injection in patients with recurrent , refractory

, metastatic adenocarcinoma (Breast colon & others) (Principal Investigator).


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17. Gemcitabine & cisplatin in patients with locally advanced / metastatic urinary

bladder cancer An observational research programme. (Principal Investigator).

18. PLUS 1 patient s attitude & lung cancer survival . A prospective observational

study in advanced non small cell lung cancer (NSCLC). (Principal Investigator).

19. An evaluation of safety & efficacy of GCSF in prevention of neutropenia in the

patients receiving cancer chemotherapy A prospective , non comparative ,

open label , multicenter study (Study protocol : IPL IBT P01-02 ). (Principal

Investigator).

20. Protocol No. P003/AC 1- 1644 01/02 : A phase I clinical & pharmacokinetic

study of DRF 1644 HCI as a daily x 5 intravenous infusion repeated every 3

weeks in adult patients with refractory solid tumours . (Principal Investigator).

21. Protocol Number TTP 200-03-01 :A randomized trial of Pivanex plus Docetaxel

or Docetaxel Monotherapy in patients with Chemotherapy resistant advanced

Nor small cell carcinoma of the lung (NSCLC). (Principal Investigator).

PROJECTS UNDER STUDY

1. A randomized , controlled open label study to evaluate the efficacy & safety of

Herceptin (Transtumuzab) in combination with the oral aromatase inhibitor

arimidex (anastrazole) compared with aridimex (anastrazole) alone as first orsecond line treatment administered to postmenopausal hormone receptor

positive (ER + ve & / or PR + ve ) patients with HER2 over expressing metastatic

breast cancer. (Principal Investigator).

2. Protccol Number 18391L/0709 : A double blind , placebo controlled , parallel

group , multicenter , randomized phase III survival study comparing zd1839

(Iressa tm) (250mg tablet) plus best supportive care versus placebo plus best

supportive care in patients with advanced NSCLC who have received one or two


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prior chemotherapy regimens & are refractory or intolerant to their most recent

regimen. (Principal Investigator).

3. Protocol BCIRG 006 Multicenter phase III randomized trial comparing

Doxurubicin & Cyclophosphamide followed by Docetaxel ( AC T ) with

Doxurubicin & Cyclophosphamide followed by Docetaxel & Trastuzumab

(Herceptin ) (AC TH ) & with Docetaxel , Carboplatin & Trastuzumab (TCH) in

the adjuvant treatment of node positive & high risk negative patients with

operable breast cancer containing her2 alteration. (Principal Investigator).

4. Protocol LF 0206 a randomized , double blind , placebo controlled , phase II

study of oral recombinant human lactoferrin (rhLF) in combination with

carboplatin & paclitaxel (C/P) chemotherapy in patients with locally advanced

and / or metastatic non small lung cancer (NSCLC). (Principal Investigator).

5. Protocol : EGF 20009 : A phase II, Open Label , Randomized , parallel group

multicenter Trial comparing two schedules of GW 572016 as First line therapy in

patients with Advanced or Metastatic breast cancer. (Principal Investigator).

6. A phase III study of DPPE (tesmilifene) combined with Epirubicin &

Cyclophosphamide versus Epirubicin & cyclosphosphamide alone as first line

treatment in Metastatic / Recurrent breast cancer. (Principal Investigator).

7. Protocol : H3E MC JMDB (a) ; A randomized phase III trial of Alimta &Cisplatin versus Gemcitabine & Cisplatin in patients with locally advanced or

Metastatic Non small lung cancer. (Principal Investigator).

8. LF 0201: A randomized , double blind , placebo controlled , phase 2 study of

oral recombinant human lactoferrin (rhLF) monotherapy in patients with locally

advanced or metastatic non small lung cancer (NSCLC) who have failed 1st or

2nd line chemotherapy . (Co- investigator)


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9. A prospective , open label study of Anastrozole in Post Menopausal women with

Hormone sensitive advanced breast cancer. ( A multicenter , post marketing

surveillance study. ) (Co- Investigator)

10. Protocol : MO 18024 ; First line Bevacizumab & Chemotherapy in Metastatic

cancer of the Colon or Rectum . An expanded access program. (Co-

Investigator).

11. A multicentric , open label , phase III Clinical trial to evaluate the safety & efficacy

of Molgramostim (Zenotech) in cancer patients with grade 3 or 4 chemotherapy

induced neutropenia . (Principal- Investigator)

12. An observational study on archived formalin fixed paraffin embedded (FFPE)

tissue to evaluate molecular markers of disease progression & response to

therapy in breast cancer. (Principal- Investigator).

13. An observational study on archived formalin fixed paraffin embedded ( FFPE)

tissue to evaluate molecular markers of response to Herceptin therapy in

metastatic breast cancer . (Principal Investigator)

PROTOCOLS TO BE INITIATED

1. Protocol : 18391L / 0706 : A Phase II Randomized , Double blind ,

placebo controlled , Multicenter comparative Study of ZD 1839 or 500mg

(Ireesa) given either continuously or concomitantly with cisplatin plusRadiotherapy for the treatment of patients with previously untreated

unresectable late stage III / IV Non Metastatic Head & Neck Squamous

Cell Carcinoma (Co- Investigator).

2. Protocol : B9E I N O348 : A phase II study evaluating the role of neo

adjuvant chemotherapy (with Gemcitabine & Cisplatin) followed by surgery

in poor prognosis but potentially respectable gall bladder cancer . (

Principal Investigator)


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Curriculum Vitae

Name: Dr. Shyam Agarwal

Chairman, Dept of Oncology, Ganga Ram Hospital, New Delhi

Education Qualification:

Institution Year Degree

Medical College (Rohtak) 1981 MBBS

PGIMER (Chandigarh) 1984 MD (Internal Medicine)

Research Training Experience:

Year Duration Institution Particulars of Work

1997-till

date

70

months

Sir Ganga Ram Hospital,

DelhiChairman, Dept of Oncology

1991-9672

months

Moolchand HospitalStem cell transplantation

Consultant, Medical Oncology

1989-9014

monthsUCLA, Los Angeles

Clinical Bone Marrow

Transplantation

Molecular Biology of Hematology.

Growth factors and their receptors

1988 2 months St. Vincent HospitalClinical Bone marrow

transplantation

1986 1 week Univ of Ulm, GermanyClinical Bone marrow

transplantation


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1985-8939

months

AIIMSStem cell research

Clinical trials in malignancies

1982 6 months PGIMER Blood bank

1981-8436

monthsDept of Medicine Clinical training

Publication: 9 papers published in national and international journals.

Awards:1. International Fogarty fellowship for training in Bone marrow transplantation and

basic medical research at UCLA, Los Angeles, USA.

2. Sliver medal for standing 1st in MD. Medicine exam

3. Silver medial for getting highest marks in Medicine in Final MBBS examination

4. Awarded senior research fellowship by ICMR after MBBS.

He has experience in conducting clinical trials and has the opportunity of presenting

approximately 50 national and international conference papers.

Documents

Neeman Presentation on Oncology