NEEMAN MEDICAL INTERNATIONAL

PRESENTATION

ON

THERAPEUTIC AREA: ONCOLOGY

 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:
Project
Indication Company Phase Status
No
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 Complete
5 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
Carcinoma induced Nausea
12 GSK III Ongoing
& Vomiting
13 Ca breast GSK III Ongoing
14 Cancer Pancreas Globeimmune II Ongoing
15 CINV AP Pharma III Ongoing

Neeman’s experience with conducting clinical trials in other therapeutic areas:

Devices

Kidney Tr ansplant / Immunology

Rheumat ology/ Or t hopedic

Vaccine

Respir at or y Diseases

HIV
Therapeutic Area

Inf ect ious Dieases

Gast r oent er ology

Car diology

Opht halmology

der mat ology

Endocr inology/ Met abolic Disor der

Ot her s

Psychiat r y/ Neur ology

Oncology

0 5 10 15 20 25
Number of Studies
PATIENT LOAD and STANDARD OF CARE FOR DIFFERENT INDICATIONS:

Head and Neck Carcinoma:

Therapeutic Area: Oncology

Indication: Head and Neck Carcinoma

Patient load site wise

Site 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
Breast carcinoma:

Therapeutic Area: Oncology

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.
Non-small cell Lung Carcinoma:

Therapeutic Area: Oncology

Indication: Non small cell lung cancer

Patient load site wise
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
Bone Metastases associated with solid tumors:

Therapeutic Area: Oncology

Indication: Bone metastases associated with solid tumors

Patient load site wise

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
Colorectal Carcinoma:
Therapeutic Area: Oncology

Indication: Colorectal Ca
Patient load site wise
Site Type of Hospital Patient Load/year
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.

Cervical Intraepithelial Neoplasia:

Therapeutic Area: Oncology

Indication: CIN
Patient load site wise
Site Type of Hospital Patient Load/year
Site 1 Public 200
Site 2 Public 250
Site 3 Private 300-350
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 possible—follow-up is imperative.

Thyroid Carcinoma:

Therapeutic Area: Oncology

Indication: Thyroid Carcinoma

Patient load site wise
Site Type of Hospital Patient Load/year
Site 1 Public 50
Site 2 Public 30
Site 3 Private 20-30
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 II–IV cancer should be
treated with adjuvant 131I therapy, when possible
Prostate Ca study:

Therapeutic Area: Oncology

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.

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 pituitary–gonadal axis
using a variety of methods or agents

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

monthly depot—has 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.
Hospitals:
 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.

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 naïve

unresectable 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).
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).
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 or
second 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
 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)
 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 plus
Radiotherapy 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)
 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 70 Sir Ganga Ram Hospital,

Chairman, Dept of Oncology
date months Delhi
72 Stem cell transplantation
1991-96 Moolchand Hospital
months Consultant, Medical Oncology
Clinical Bone Marrow
14 Transplantation
1989-90 UCLA, Los Angeles
months Molecular Biology of Hematology.
Growth factors and their receptors
Clinical Bone marrow
1988 2 months St. Vincent Hospital
transplantation
Clinical Bone marrow
1986 1 week Univ of Ulm, Germany
transplantation
 39 Stem cell research
1985-89 AIIMS
months Clinical trials in malignancies
1982 6 months PGIMER Blood bank
36
1981-84 Dept of Medicine Clinical training
months

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.