Cancer Information

Clinical Trials Offered by Georgia Cancer Specialists

The following tables summarize the pharmaceutical industry-sponsored clinical trials offered to GCS patients:

Active Trials
Trial	Disease	Phase
Ascenta	Solid tumor	I
GSK	ITP	II
BMS	Colorectal	II
Cell Genesys	Prostate	II
Kosan/Roche	Prostate-second line	II
Novartis	Prostate	II
UAB	Breast-neo-adjuvant	II
Amgen	Colorectal	III
BMS	Colorectal	III
GSK	Breast-hormonal therapy	III
NCI-Canada	Breast cancer prevention	III
OrthoBiothech	Breast	III
Schering-Plough	MDS/CMML	III
J&J	Multiple myeloma	III
BMS	CML	III
Novartis	GIST	IV
Novartis	MM	IV
Genentech	Breast - HER2+	IV
Genentech	NHL	IV

 

Pending Trials
Trial	Disease	Phase
Ascenta	CLL	I
GSK	Ovarian	I
Genentech	Colorectal	II
EMD	Lung	III
Sanofi-Aventis	Breast	IV

Research at Georgia Cancer Specialists

Approach

In addition to offering patients access to national cooperative group clinical trials and pharmaceutical-based clinical trials—primarily Phase III and IV trials—Georgia Cancer Specialists (GCS) has partnered with the University of Alabama-Birmingham Comprehensive Cancer Center (UABCCC) to bring to Georgia Phase I and II trials, the most novel cancer therapies available.

• GCS takes high-tech, innovative therapies developed in an academic center and brings them to patients in community offices.
• The GCS-UABCCC partnership allows UABCCC to improve accrual of high priority studies while assuring that quality, regulated research is performed. It gives GCS patients access to cutting-edge research and cancer therapies.
• GCS conducts research in five offices: Kennestone, Northside, Stemmer, Fayetteville and Macon.
• GCS offers clinical trials in the major disease categories: lung, breast, lymphoma, colon, and prostate.
• GCS offers patients access to innovative cancer therapies, including antiangiogenesis drugs, which prevent tumors from growing their own blood supplies.
• Because clinical trials are so accessible, an average of 18% of GCS oncology patients participate in research (including GCS trials, community clinical oncology program trials, and stem cell transplants), compared to the national average of 2%.

Please be aware that Phase I trials are not designed to show effectiveness; they are designed to show that the drug is not toxic in humans. Little is known about the drugs in Phase I trials, because this is when they are usually tested in humans for the first time, or are evaluations of a new dosage or new mode of administration.

Focus

The focus of the GCS research department is targeted cancer therapy, which unlike chemotherapy attacks tumor cells selectively.

Milestones

• Through its partnership with UABCCC, GCS is the only private oncology practice in Georgia to offer Phase I clinical trials.
• Dr. Mansoor Saleh, GCS medical oncologist and professor of medicine and pathology at UAB, holds the first Department of Defense grant awarded in the United States to a private practice oncologist for breast cancer research. The practice has partnered with the university and is using the multimillion-dollar grant to establish the GCS-UAB Clinical Trials Network.
• Through its partnership with UABCCC, GCS administered the following novel reagents for the first time in Georgia: C225 anti-EGFR antibody for colon cancer, C225 anti-EGFR + RT for head/neck cancer, C225 anti-EGFR + chemo for head/neck cancer, Radioactive Y2B8 monoclonal antibody for lymphoma, Monoclonal antibody BR96-Doxorubicin immunoconjugate for colon and breast cancer, and STI-571 (also known as Gleevec) for chronic myelogenous leukemia (CML).
• Dr. Janice Galleshaw, GCS medical oncologist, is the Principal Investigator for the STAR Trial (Study of Tamoxifen and Raloxifene) for breast cancer prevention in the Atlanta region. The STAR Trial is the largest randomized clinical study of its kind, with 22,000 women taking part.
• GCS is consistently ranked as a top enroller for many national and international trials.
• Since 2000, the GCS research department has published multiple manuscripts and abstracts and has present research results at national and international meetings.

Currently there are five research sites with five lead investigators that monitor all patients on clinical trials. Dr. Mansoor Saleh monitors trials from our Northside location, Dr. Melvin Moore monitors trials from our Stemmer location, Dr. Cheryl Jones monitors trials from our Macon-Coliseum location, Dr. Rodolfo Bordoni monitors trials from our Kennestone location, and Dr. Shyam Khanwani monitors trials from our Fayetteville location. The research team is comprised of physicians and specialized clinical staff trained in research design, data collection, and analysis. Currently, over twenty clinical trials are being conducted with over 200 patients participating.

 Our affiliation with the ARCCOP allows our patients access to large national cooperative trials. On average we accrue over 60 patients per year to these trials. The following table summarizes the active ARCCOP protocols offered to GCS patients:

Active ARCCOP Protocols
Trial	Disease	Phase
SWOG 8819	Lymphoma	-
SWOG 8855	H&N	-
SWOG 8947	Lymphoma	-
SWOG 9007	Cytogen	-
SWOG 9245	Tissue Repos	-
SWOG 9336	Lung	III
SWOG 9419	GI	-
SWOG 9444	Tissue Repos	-
SWOG C9581	Colon	III
SWOG C9710	APL	III
SWOG E1199	Breast	III
SWOG E2496	Hodgkins	III
SWOG E2998	AML	III
SWOG E3695	Melanoma	III
SWOG E5597	Lung	-
SWOG JMA 17	Breast	III
SWOG N9741	Colon	III
SWOG N9841	Colon	III
SWOG S0000	Prostate	-
SWOG S0008	Melanoma	III
SWOG S0014	NHL	II
SWOG S0022	Lung	II
SWOG S0033	GIST	III
SWOG S9701	Ovarian	III
SWOG S9807	H&N	-
SWOG S9811	CNS	II
SWOG S9832	Breast	-
SWOG S9900	Lung	III
SWOG S9910	Tissue Repos	-
SWOG S9916	Prostate	III
SWOG S9917	Prostate	-
SWOG S9921	Prostate	III
SWOG S9922	Myeloma	III
SWOG S9926	GIST	II
SWOG S9927	Breast	III
NSABP B-30	Breast	III
NSABP B-31	Breast	III
NSABP B-32	Breast	III
NSABP B-34	Breast	III
NSABP BI-65	Breast	-
NSABP C-07	Colon	III
NSABP P-2	Breast	-
DM 97-182	Lymphoma	II
ID 95-236	Bladder	-
RTOG 93-11	Lung	I/II
RTOG 96-01	Prostate	III
RTOG 97-04	Pancreatic	III
RTOG 97-14	Bone Mets	III
RTOG 98-01	Lung	III
RTOG 98-04	Breast	III
RTOG 98-11	Anal	III
RTOG 99-01	H&N	-
RTOG 99-03	H&N	III
RTOG 99-04	Stomach	II
RTOG 99-05	Endometrial	-
RTOG 99-10	Prostate	III
RTOG 99-13	H&N	-

 

Our physicians have also participated in autologous stem-cell transplants in breast cancer, lymphomas, leukemias, ovarian cancer and multiple myeloma through our affiliation with ROI. Our physicians have enrolled hundreds of patients in over 150 clinical trials during the last seven years.

We are continuing to expand our clinical research program by increasing the number of trials offered to our patients for front line and salvage therapies.

For more information, please call our research department at (770) 496-9400, or fill out our information request form.