SHIRISH M. GADGEEL
Office Address
4 HWCRC, 4100 John R
Detroit, MI 48201
Tel: (313) 576-8753
FAX: (313) 576-8699
EDUCATION
Baccalaureate:
Graduate:
1983-1988
Grant Medical College and J.J. Group of Hospitals, University of
Bombay, Bombay, India. Bachelor in Medicine and Surgery (M.B;B.S.)
TRAINING:
Postgraduate:
1989-1992
1993-1994
1994-1996
1996-1999
1999-2000
Grant Medical College and J.J. Group of Hospitals, University of
Bombay, Bombay, India. Three year Residency in Internal Medicine. MD.
LaGuardia Hospital, Forest Hills, NY. Internship in Internal Medicine.
MD.
Wayne State University, Detroit, MI. Residency in Internal Medicine.
MD.
Wayne
State
University,
Detroit,
MI.
Fellowship
in
Hematology/Oncology. MD.
Wayne State University, Detroit, MI. Fellowship in Bone Marrow
Transplantation. MD.
FACULTY APPOINTMENTS:
1992-1993
Staff Physician, Department of Internal Medicine, JJ Group of Hospitals,
University of Bombay.
2000-
Associate Professor, Division of Hematology&Oncology, Department of
Internal Medicine, Karmanos Cancer Center/Wayne State University,
Detroit, MI.
HOSPITAL APPOINTMENTS:
20062006-
Member of the Human Investigation Committee at Wayne State
University School of Medicine (MP4)
Elected to the Medical Staff Committee of the Karmanos Cancer Hospital
20062006200620012005-
Physician In-charge of 5 Webber North Hematology/Oncology Floor
Member of the Physician/Nursing Leadership at Karmanos Cancer
Hospital
Member of the Utilization Review Committee of Karmanos Cancer
Hospital
Member of the Protocol Review Committee, Karmanos Cancer Center
Member of the Clinical Care Planning Committee of the Karmanos Cancer
Hospital
MAJOR PROFESSIONAL SOCIETIES:
1. Member of the American Society of Clinical Oncology
2. Member of the American College of Chest Physicians.
LICENSURE AND BOARD CERTIFICATION:
Licensure:
Michigan Board of Medicine
Board Certification:
2000
1999
1996
1992
1989
Diplomate in Hematology, American Board of Internal Medicine.
Diplomate in Medical Oncology, American Board of Internal Medicine.
Diplomate in Internal Medicine, American Board of Internal Medicine.
Board Certified in Internal Medicine, University of Bombay.
Bachelor of Medicine & Surgery (M.B;B.S.), University of Bombay.
HONORS / AWARDS:
2005
2000
1999
1997
1996-1997
1996
1992
Wayne State University School of Medicine Teaching Award
Scored in the top ten percentile at the Hematology Boards
Scored in the top ten percentile at the Medical Oncology Boards
Merit Award, American Society of Clinical Oncology.
Outstanding Fellow, Division of Hematology & Oncology, Wayne State
University, Detroit, MI.
Scored in the top ten percentile at the Internal Medicine Boards.
Second position , Internal Medicine Boards, University of Bombay.
SERVICE:
1. Patient Care:
Expertise in
A. Thoracic Oncology including Lung cancer and Mesothelioma
B. Sarcomas
Expertise in Developmental Therapeutics in Oncology.
2. Public Presentations as an Expert in Discipline:
A. 2001- Gildas Club of Metro Detroit- Lung Cancer
B. 2005- Patient Forum at Weisberg Clinic- Lung Cancer
C. 2005- Channel 4 (WDIV)- News item on Lung Cancer
D. 2005- 2nd Annual Gianni Ferraroti Lung Cancer Foundation- Lung Cancer.
3. Journal/Editorial Activity:
Reviewer for the following Journals1.
2.
3.
4.
5.
6.
International Journal of Radiation Oncology Biology Physics.
Lung Cancer
Clinical Lung Cancer
Cancer
Expert Review of Anticancer Therapy
Annals of Surgical Oncology
4. National Boards and Committees:
1. Member of the Thoracic Sterring Committee of the Southwest Oncology
Group.
2. Member of the Early Therapeutics Steering Committee of the Southwest
Oncology Group.
TEACHING:
1. Years at Wayne State University: 6 years.
2. Courses taught at Wayne State University:
a. Hematology and Oncology Fellows/ Internal Medicine Residents
i. Teaching Rounds on Medical Oncology and Hematology floors
ii. Medical Oncology Consults
iii. Thoracic Oncology and Sarcoma Outpatient Clinics
iv. Journal Club
v. Hematology/Oncology Case Conference
b. Medicine Students
i. Physical Diagnosis
c. Cancer Biology Students
i. Thoracic Oncology and Sarcoma Outpatient Clinics
3. Presentations of Hematology/Oncology fellows for the Annual meeting of
American Society of Clinical Oncologya. 2002- Dr. Tripathi had a presentation at ASCO. (Abstract No. 5 listed
below)
b. 2003- Two fellows- Dr. Thatai and Dr. Shehadeh had presentations under
my guidance. (Abstracts No. 6 and 7 listed below)
c. 2004- Dr. Shehadeh had a presentaion under my guidance. (Abstract No.
17 listed below).
d. 2006- Dr. Jiang had a presentation under my guidance. (Abstract No. 25
listed below).
4. Ongoing Research Projects with Fellows/Residents
a. Dr. Srinivasan, Hematology and Oncology Fellow is working on a
protocol of evaluating Zometa in Non-Small Cell Lung Cancer.
b. Dr. Prakash, Internal Medicine resident at Sinai-Grace is working on a
retrospective review of Radiation pneumonitis in NSCLC patients treated
with concurrent chemotherapy and radiation.
PUBLICATIONS:
Original Observations:
Kalemkerian GP, Slusher R, Ramalingam S, Gadgeel S, Mabry M. Growth inhibition
and induction of apoptosis by Fenretinide in Small Cell Lung Cancer cell lines. J Natl
Cancer Inst. 1995; 87(22): 1674-80.
2. Ramalingam S, Pawlish K, Gadgeel S, Demers R, Kalemkerian GP. Lung Cancer in
Young Patients: analysis of the SEER database. J Clin Oncol. 1998; 16(2): 651-657
3. Philip PA, Zalupski MM, Gadgeel S, Hussain M, Shields A. A phase II study of
Carboplatin and Paclitaxel in the treatment of patients with advanced Esophageal &
Gastric cancer. Semin. Oncol. 1997; 24 (6 Suppl. 19): 1986-88.
4. Gadgeel S, Ramalingam S, Cummings G, Kraut MJ, Wozniak AJ, Gaspar LE,
Kalemkerain GP. Lung cancer in < 50 years of age : the experience of an academic
multidisciplinary program . Chest. 1999; 115(5):1232-36
5. Hussain M, Gadgeel S, Kucuk O, Wei Du, Salwen W, Ensley J. Paclitaxel, Cisplatin
and 5-Flurouracil in patients with advanced/recurrent head and neck cancer. Cancer.
1999;86(11):2364-69.
6. Gadgeel SM, Severson RK, Kau Y, Graff J, Weiss LK, Kalemkerian GP. Impact of
race in lung cancer : Analysis of temporal trends from a surveillance, epidemiology,
and end results database.Chest 2001;120:55-63
7. Gadgeel SM, Shields A, Heilbrun L, Labadidi S, Chaplen R, Zalupski M, Philip P.
Phase II study of Carboplatin and Paclitaxel in the treatment of patients with
advanced gastric cancer. Am J Clin Oncol 2003;26:37-41.
8. Gadgeel, S.M., Bionpally, R.R., Heilbrun, L.K., Wozniak, A., Jain, V., Redman, B.,
Zalupski, M., Wiegand, R., Parchment, R., LoRusso, P.M. A Phase I Clinical Trial of
Spicamycin Derivative KRN5500 (NSC 650426) Using a Phase I Accelerated
Titration “2B” Design. Invest New Drugs 2003;21:63-74
9. Gadgeel SM, Wozniak A, Boinpally RR, Wiegand R, Heilbrun L, Jain VK,
Parchment R, Lebwohl D, Colevas C, LoRusso P. Phase I clinical trial of BMS247550, a derivative of Epothilone B. Clin Cancer Res 2005;11:6233-9.
10. Du W, Reeves JH, Gadgeel S, Abrams J, Peters WP. Cost-effectiveness and lung
cancer clinical trials. Cancer 2003; 98:1491-6.
1.
11.
12.
13.
14.
15.
16.
17.
18.
LoRusso PM, Adjei AA, Varterasian M, Gadgeel S, Reid J, Mitchell DY, Hanson L,
Deluca P, Bruzek L, Piens J, Asbury P, Van Becelaere K, Herrera R, Sebolt-Leopold
J, Meyer MB. Phase I and Pharmacodynamic Study of the Oral MEK Inhibitor CI1040 in Patients With Advanced Malignancies. J Clin Oncol 2005; 23:5281-93.
Du W, Gadgeel SM, Simon MS. Predictors of enrollment in lung cancer clinical
trials. Cancer 2006;106:420-5.
El-Rayes BF, Gadgeel S, Parchment R, LoRusso P, Philip P. A phase I study of
flavopiridol and docetaxel. Invest New Drugs 2006 January 28, Epub ahead of print.
Gadgeel SM. Smoking History: Tumor Biology and Clinical Pharmacokinetic
Implications in patients with lung cancer. Clin Lung Cancer 2006;7:369-70.
Gadgeel SM, Ruckdeschel JC, Heath EI, Heilbrun LK, Venkatramanamoorthy R,
Wozniak A. Phase II study of Gefitinib, an Epidermal Growth Factor Receptor
Tyrosine Kinase Inhibitor (EGFR-TKI), and Celecoxib, a Cyclooxygenase-2 (COX2) inhibitor, in Patients with Platinum Refractory Non-Small Cell Lung Cancer
(NSCLC). J Thorac Oncol (In press).
Alousi AM, Boinpally R, Wiegand R, Parchment R, Gadgeel S, Heilbrun LK,
Wozniak AJ, Deluca P, Lorusso PM. A phase 1 trial of XK469: Toxicity profile of a
selective topoisomerase IIbeta inhibitor. Invest New Drugs 2007;25:147-54.
El-Rayes BF, Gadgeel S, Shields AF, Manza S, Lorusso P, Philip PA. Phase I study
of bryostatin 1 and gemcitabine. Clin Cancer Res 2006;12:7059-62.
Wozniak A, Belzer K, Kraut MJ, Kucuk O, Gadgeel S, Kalemkerian G, Venkat R,
Heilbrun L. Mature results of a phase II trial of Gemcitabine and paclitaxel given
every two weeks in patients with advanced Non-Small Cell Lung Cancer. Clin Lung
Cancer (In press).
Review Articles:
1.
2.
3.
4.
5.
Flaherty LE, Gadgeel SM. Biochemotherapy of Melanoma. Seminars in Oncology
2002;29:446-55.
Gadgeel SM, Kalemkerian GP. Racial differences in Lung Cancer. Cancer Metastasis
Rev 2003;22:39-46.
Gadgeel SM, Pass HI. Novel Combinations using Pemetrexed in Malignant
Mesothelioma. Clin Lung Cancer 2004;Suppl 2:S61-6.
Gadgeel S, Pass HI. Malignant Mesothelioma. Community Oncology. May 2006.
Wozniak A, Gadgeel SM. Adjuvant Treatment of Non-Small Cell Lung Cancer: How
Do We Improve the Cure Rates Further? Oncology 2007;21:163-71.
Book Chapters:
1. John C. Ruckdeschel, M.D. Ann G. Schwartz, Ph.D. Gerold Bepler, M.D., Ph.D. Lynn
Coppage, M.D. Fulvio Lonardo, M.D. Omer Kucuk, M.D. Harvey I. Pass, M.D. Henry
Wagner, M.D. Antoinette J. Wozniak, M.D. Shirish M. Gadgeel, M.D. Clinical
Oncology. Eds. Abelhoff et al. Lung Cancer 2004.
2. Gadgeel SM, Wozniak A. Clinical Presentation of Non-Small Cell Lung Cancer: Principles
and Practice. Eds. Pass HI, Carbone DP, Johnson DH, et al. Lippincot Williams Wilkins.
2004
3. Wozniak A, Gadgeel SM. Paraneoplastic Syndromes. Oncology: An Evidence- Based
Approach. Eds. Chang et al. Springer Ala. 2005.
ABSTRACTS & PRESENTATIONS:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
A phase I dose escalation trial of ZD6126, a novel vascular targeting agent, in
patients with cancer refractory to other treatments. LoRusso PM, Gadgeel S, Wozniak
A, Barge A, McKinley M, McKinlay T, Swaisland A, Wheeler C. Proceedings
AACR-NCI-EORTC International Conference on Molecular Targets and cancer
Therapeutics 2001; 8(abstract 36).
Gadgeel SM, LoRusso PM, Wozniak AJ, Wheeler C. A dose escalation study of the
novel vascular-targeting agent, ZD6126, in patients with solid tumors. Proc Am Soc
Clin Oncol 2002. Abstract 438
Du W, Gadgeel SM, Peters WP. Economic Analysis of Lung Cancer clinical trial
participation demonstrates cost-effectiveness but disparities by insurance coverage
and race. Submitted in December 2001 for ASCO 2002. Abstrac 1224.
LoRusso, P.M., Adjei, A.A., Meyer, M.B., Wozniak, A., Gadgeel, S.M., Hanson, L.J.,
Reid, J.M., Mitchell, D.Y., Bruzek, L.M., Leopold, J.S., Herra, R., Van Becelaere, K.,
Carlson, T., Packard, C., Gulyas, S.W., Erlichman, C. A Phase I Clinical and
Pharmacokinetic Evaluation of the Oral MEK Inhibitor, CI-1040, Administered for
21 Consecutive Days, Repeated Every 4 Weeks in Patients with Advanced Cancer.
ASCO 2002. Abstract 321.
Tripathi, R., Gadgeel, S.M., Wozniak, A.J., Flaherty, L.E., Shields, A.F., Colevas,
D.A., Lebwohl, D., LoRusso, P.M.
Phase I Clinical Trial of BMS-247550
(Epothilone B Derivative) in Adult Patients with Advanced Solid Tumors. ASCO
2002. Abstract 407.
Gadgeel SM, Thatai L, Kraut M, Wozniak A, Worden F, Ward D, Belzer K, Hodges
C, Kalemkerian GP. Phase II study of celecoxib and docetaxel in patients with nonsmall cell lung cancer (NSCLC) with progression after platinum-based therapy.
ASCO 2003. Abstract 2749
Shehadeh N, Kalemkerian GP, Wozniak A, Kraut M, Belzer K, Ward D, Hodges C,
Gadgeel SM Preliminary results of a phase II study of celecoxib and weekly
docetaxel in elderly (≥ 70 yrs) or PS2 patients with advanced non-small cell lung
cancer (NSCLC). ASCO 2003. Abstract 2758
Scholnik A, Given CW, Chapman R, Gadgeel S, Decker D, Axelson J. Psychological
Characteristics of Patients who Enter Clinical Trials. ASCO 2003. Abstract 2163
McCormick J, Gadgeel SM, Helmke W, Chaplen R, DeCellis A, Bai S, LoRusso PM.
Phase I study of BMS-387032, a cyclin dependent kinase (CDK) 2 inhibitor. ASCO
2003. Abstract 835
LoRusso P, Rinehart J, Anderson J, Gadgeel S, Shah B, Thornton J, Rothermel J. A
Phase I Dose-Escalation Trial Investigating the Safety and Tolerability of EPO906
Plus Gemcitabine in Patients With Advanced Cancer. ASCO 2003. Abstract 627.
Wozniak AJ, Belzer K, Kucuk O, Gadgeel S, Ward, Kraut M: Mature results of nonplatinum-based [Gemcitabine and Paclitaxel (GEMPAC) phase II study. ASCO2003.
Abstract 2807.
12. M.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
Beeram, C. H. Takimotos, S. Gadgeel, M. Garrison, M. Hill, B. cooke, M.
Ducharme R, De Jager, E.K. Rowinsky, P. LoRusso: Phase I and Pharmacokinetics
(PK) of DJ-927, Orally Administered Taxane, in Patients with Advanced
Malignancies. ASCO 2003. Abstract 524
B. Patel, B. F. El-Rayes, S. M. Gadgeel, P. Lorusso, P. A. Philip. A phase I study of
flavopiridol and docetaxel. ASCO 2003. Abstract 932.
D. Ibrahim, B. F. El-Rayes, S. M. Gadgeel, P. Lorusso, P. A. Philip. A phase I study
of the protein kinase C modulator bryostatain-1 and gemcitabine. ASCO 2003.
Abstract 930.
SM Gadgeel, N Shehadeh, M Kraut, A Wozniak, K Belzer, D Ward, C Hodges, R
Parchment, R Chaplen, GP Kalemkerian. Preliminary results of a phase II study of
celecoxib and weekly docetaxel in elderly (≥ 70 yrs) or PS2 patients with advanced
non-small cell lung cancer (NSCLC). Oral presentation at IASLC 2003.
B Schneider, FP Worden, SM Gadgeel, CM Hodges, RE Parchment, MJ Kraut, and
GP Kalemkerian. Phase II study of Fenretinide in patients with small cell lung cancer
(SCLC) with progression after first- or second-line chemotherapy. IASLC 2003.
Gefitinib and celecoxib in patients with platinum refractory non-small cell lung
cancer (NSCLC). SM Gadgeel, NJ Shehadeh, JC Ruckdeschel, RA Chaplen, K
Belzer, A Wozniak. Proc Am Soc Clin Oncol 2004;23:636, abstract 7094.
RA Chaplen, GP Kalemkerian, A Wozniak, N Shehadeh, JC Ruckdeschel, MJ Kraut,
Lheilbrun, R Parchment, SM Gadgeel. Celecoxib (Cel) and weekly docetaxel (doc) in
elderly and PS2 patients (pts) with advanced non-small cell lung cancer (NSCLC)..
Proc Am Soc Clin Oncol 2004;23:638, abstract 7102.
BJ Schneider, F Worden, S Gadgeel, C Hodges, R Parchment, J Zweibel, M Kraut, G
Kalemkerian. Phase II study of fenretinide in patients with small cell lung cancer
(SCLC) with progression after first or second line chemotherapy. Proc Am Soc Clin
Oncol 2004;23:687,abstract 7299.
SK Syed, M. Beeram, CH Takimoto, J Jakubowitz, M Kimura, M Ducharme, S
Gadgeel, R DeJager, E Rowinsky, P LoRusso. Phase I and pharmacokinetics (PK) of
DJ-927, an oral taxane, in patients with advanced cancers. Proc Am Soc Clin Oncol
2004;23:137,abstract 2028.
AM Alousi, R Parchment, R Boinpally, S Gadgeel, R Weigand, J McCormick, P
LoRusso. Phase I clinical trial of XK469 in patients with chemo-refractory solid
tumors. Proc Am Soc Clin Oncol 2004;23:132, abstract 2020.
Simon GR, Janne PA, Langer CJ, Verschraegen CF, Dowlati A, Gadgeel S, Kelly K,
Taylor L, Obasaju CK, Kindler HL. A phase 2 clinical trial of pemetrexed (P) and
gemcitabine (G) as front line chemotherapy for patients with peritoneal mesothelioma
(PM). J Clin Oncol 2005; Abstract 7235.
SM Gadgeel, S Ali, P Philip, A Wozniak, F Sarkar. Epidermal growth factor receptor
(EGFR) mutational status of non-small cell lung cancer cells (NSCLC) may
determine the outcome of dual blockade of EGFR and cyclooxygenase-2 (COX-2).
Proc Amer Assoc Cancer Res 2006;47:[Abstract 1245].
SM Gadgeel, S Ali, P Philip, A Wozniak, F Sarkar. Dual blockade of epidermal
growth factor receptor (EGFR) and cyclooxygenase 2 (COX 2) may be dependent
upon the EGFR mutational status in non-small cell lung cancer (NSCLC) cell lines. J
Clin Oncol 2006;24:18S- Abstract 7170.
25. P Jiang, M Choi, D Smith, L Heilbrun, SM Gadgeel. Characteristics and outcomes of
cancer patients >80 years treated with chemotherapy at a comprehensive cancer
center. J Clin Oncol 2006;24:18S- Abstract 8548.
26. GR Simon, PA Janne, C Langer, V Clarie, A Dowlati, SM Gadgeel, K Kelly, Z Ye,
CK Obasaju, KE Hood, HL Kindler. A finalized phase II report of pemetrexed (P)
plus gemcitabine (G) as front-line chemotherapy for patients with peritoneal
mesothelioma (PM). J Clin Oncol 2006;24:18S- Abstract 2050.
27. PM LoRusso, E Heath, M Valdivieso, M Pilat, A Wozniak, S Gadgeel, A Shields, T
Puchalski, R Ewesuedo. Phase I evaluation of AZD2171, a highly potent and
selective inhibitor of VEGFR signaling, in combination with selected chemotherapy
regimens in patients with advanced solid tumors. J Clin Oncol 2006;24:18S- Abstract
3034.
28. BJ Schneider, S Gadgeel, N Ramnath, F Worden, A Wozniak, J Ruckdeschel, GP
Kalemkerian. Phase II trial of imatinib maintenance therapy after irinotecan and
cisplatin in patients with c-kit positive extensive-stage small cell lung cancer (ES
SCLC). J Clin Oncol 2006;24:18S- Abstract 17089.
PRESENTATIONS:
International/National Meetings:
1. International Association of Study of Lung Cancer (IASLC)- Vancouver, Canada
2003.
Presentation of Preliminary results of a phase II study of celecoxib and weekly docetaxel in
elderly (≥70yrs) or PS2 patients with advanced non-small cell lung cancer (NSCLC).
International Association of Study of Lung Cancer 2003; Abstract 110.
2. 2005- Scientific Symposium of the Thoracic Committee of the Southwest Oncology
Group. Pharmacokinetics of Erlotinib in Smokers and Dosing Implications.
Regional/Local Meetings:
1.
2.
3.
4.
2001- Bixby Medical Center, Bixby, MI- Advances in Lung Cancer
2001- Adrian Medical Center, Adrian, MI- Advances in Lung Cancer.
2002- Michigan State University, Lansing, MI. COX-2 Inhibitors in Cancer.
2002- Northern Michigan Cancer Center, Petoskey, MI. New Perspectives in Lung
Cancer.
5. 2003-Oncology Nursing Society- Kalamazoo, MI- Update on Lung Cancer.
6. 2003- Association of Physicians of Indian Origin- Michigan Chapter- Cancer
Screening.
7. 2003- University of Michigan, Ann Arbor, MI. COX-2 and Lung Cancer.
8. 2003- Aventis Speaker’s Training Program, NY, NY. Lung Cancer in the Elderly.
9. 2004- Wayne State Univeristy, Detroit, MI. COX-2 and Cancer.
10. 2004- William Beaumont Hospital, Royal Oak, MI. Peri-operative Treatment of
NSCLC.
11. 2004- University of Wisconsin, LaCrosse, WI. Small Cell Lung Cancer- Update.
12. 2004- Duluth Clinic, Duluth, MN. Small Cell Lung Cancer- Update.
13. 2004- Ohio River Hospital, Columbus, OH. Peri-operative Treatment of NSCLC.
14. 2004- Sparrow Hospital, Lansing, MI. Recent advances in NSCLC.
15. 2004- St. John’s Hospital, Macomb, MI. Role of EGFR inhibitors in NSCLC.
16. 2005- Alpena General Hospital, Alpena, MI. Clinical Issues in the Management of
NSCLC.
17. 2005- Northern Michigan Cancer Center, Petoskey, MI. Multi-modality management
of NSCLC.
18. 2005- Allegheny Hospital, Pittsburgh, PA- ASCO 2005 update of Lung Cancer.
19. 2006- Oncology Nursing Society, Detroit Chapter. Treatment of Sarcoma.
20. 2006- St. Mary’s Hospital, Chicago, IL. Management of Advanced NSCLC.
21. 2006- Cook County Hospital, Chicago, IL. Management of advanced NSCLC.
22. 2006- Michigan Society of Hematology and Oncology- Annual Board Review for
Fellows. Sarcoma Management.
23. 2006- Sacred Heart Hospital, Pensacola, FL, Oncology Grand Rounds- New
Approaches to Lung Cancer. Translating Clinical Research into Clinical Practise
24. 2006- Crittenton Hospital, Rochester, MI, Internal Medicine Grand Rounds- Novel
New Approaches to Lung Cancer. Translating Clinical Research into Clinical Practise
25. 2006- Alpena General Hospital, Alpena, MI, Oncology Grand Rounds- New
Approaches to Lung Cancer. Translating Clinical Research into Clinical Practise
26.
CURRENT RESEARCH:
Principal Investigator:
Investigator Initiated Institution Studies:
Clinical:
Therapeutic:
Phase II of concurrent cisplatin/pemetrexed and RT followed by consolidation
gemcitabine in patients with stage III NSCLC. Grant funding from Lilly
Pharmaceuticals- $130,000. July 2005-June 2007.
2. Phase 2 study of AZD2171 in combination with pemetrexed in relapsed Non-Small
Cell Lung Cancer. Grant funded under NCI grant UO-1, PI- Dr. Patricia LoRusso.
Grant funding for correlatives approved by Astra-Zeneca. Accruing
3. Assessment of feasibility and efficacy of the addition of ZD6474 to carboplatin and
paclitaxel administered neo-adjuvantly in stage IB, II, III (T3, N1) Non-Small Cell
Lung Cancer. Grant funding approved by Astra-Zeneca. Proposed start date March
2007.
4. Evaluation of bevacizumab and weekly docetaxel in elderly (≥ 75 years) patients with
advanced NSCLC. Grant funding approved by Genentech. Proposed start date April
2007.
1.
5.
Phase II study evaluating the effect of Zometa on Standardized Uptake Value (SUV)
on FLT PET scans in Non-Small Cell Lung Cancer Patients (NSCLC). Grant funding
approved by Novartis. Proposed start date April 2007.
Retrospective Review:
1. Outcome of chemotherapy in Cancer Patients ≥ 75 years. A retrospective review
with fellows in Hematology/Oncology.
2. Incidence of Radiation pneumonitis in lung cancer patients treated with
chemotherapy and radiation, at Karmanos Cancer Institute. A retrospective
review
Pre-Clinical:
1. Influence of EGFR bio-marker status of Non-Small Cell Lung Cancer on the efficacy
of dual blockade by a COX-2 inhibitor and EGFR tyrosine kinase inhibitor. Drug
provided by Astra-Zeneca. Grant Funded by Karmanos Cancer Institute. $15,000.
Investigator Initiated National Studies:
1.
S0528 Phase I study evaluating the combination of lapatinib (GW572016) and
everolimus (RAD001) in patients with advanced solid tumors. Accruing.
Multicenter Studies- Site Principal Investigator (Active)
1.
2.
3.
4.
5.
6.
A Phase III, Multicenter, Placebo-Controlled, Double Blind, Randomized Clinical
Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva
compared with Tarceva Alone for Treatment of Advanced Non-small cell lung cancer
after failure of standard first-line chemotherapy. Grant funding from Genentech.
Period September 2005-December 2007. $105,600. Percent effort-5%.
A Phase 2 Study of the MED Inhibitor PD-0325901 in Patients with Advanced NonSmall Cell Lung Cancer. Grant funding from Pfizer. November 2005-October 2008.
$52,123. Percent effort 5%.
Phase II study evaluating AZD2171 in patients with relapsed Small Cell Lung Cancer
(SCLC).Funded by NCI funded Mayo Clinic Phase II consortium.
Phase I, dose-escalation, sequential-cohort study of the safety, tolerability, and
pharmacokinetics of intravenous AVE0005 (VEGF trap) in combination with
intravenous docetaxel/cisplatin/5-fluorouracil administered every 3 weeks in subjects
with advanced solid malignancies. Grant funding from Sanofi-Aventis. December
2005-November 2008. $143,000.
A multicenter phase II of sorafenib (BAY43-9006) in non-GIST sarcomas. October
2006-November 2007.
A phase II trial of BAY 43-9006 in advanced soft tissue sarcomas- A Southwest
Oncology Group Study. October 2006-Spetember 2007.
Randomized study evaluating carboplatin and pemetrexed with carboplatin and
etoposide in patients with small cell lung cancer. Grant funding from Eli Lilly.
Contract being negotiated. November 2006-October 2008
8. Phase II study of XL647 in patients with Non-Small Cell Lung Cancer. Grant funding
from Exlexis. Contract ebing negotiated. October 2006- September 2008.
9. A phase Ib study investigating the combination of RAD001 with cisplatin and
etoposide in patients with extensive stage small-cell lung cancer not previously
treated with chemotherapy. Grant funding from Novartis. Contract being negotiated.
Expected start date December 2006.
7.