Adult Hemophilia Clinic

Solid Tumor Oncology

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Fellowship Program

Sickle Cell Center

MB CCOP

Clinical Trials

Pediatric Oncology

Patient Information

Internal Medicine Residency Program

M.D./Ph.D. Program

MCG Healthcare System

Information and Referrals
Contact Elizabeth Jones at :
Administrative Office
Phone: 
(706) 721-2505 
1-800-736-CARE
Fax: 
(706) 721-8302
Address:
BAA - 5407
1120 15th Street
Augusta, GA 30912-3125

Hematology/Oncology
Research  
Clinical Trials 

Contacts for MCG MB CCOP:

Brain

 N0177 (05-10-083), PI: Alfredo Volocshin, MD; MCG

A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination with Radiation Therapy in Gliblastoma Multiforme

•  Histologically confirmed glioblastoma multiform (grade 4) gliosarcomas and other grade 4 astrocytoma may be included

• ≥ 18 years of age

•  ECOG performance status ≤ 2

• Life expectancy ≥ 6 months

• Must be enrolled ≥  1 week after, but ≤ 4 weeks after biopsy or surgery

Breast

Preservation of Ovarian Function in Young Women Treated with (NEO) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the GnRH Agonist (Triptorelin During Chemotherapy

• Pre-menopausal women ages 18-45
• Newly diagnosed with pathologically proven breast cancer
• Clear Margins
• Scheduled to receive neo-adjuvant or adjuvant chemotherapy

A Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Risedronate (Actonel) for Prevention of Bone Loss in Premenopausal Women Undergoing Chemotherapy for Primary Breast Carcinoma

• Pre-menopausal women ages ≥ 18 years
• No prior bilateral oophorectomy or estrogen replacement therapy
• Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (Stages I-IIIB)

N00C9 (04-11-164), PI: Daron Ferris, MD; MCG

The Use of Ginkgo Biloba for the Prevention of Chemotherapy-Related Cognitive Dysfunction

·         Women ages ≥ 18 years of age not pregnant or lactating

·         Women with newly diagnosed breast cancer scheduled to receive standard doses of adjuvant chemotherapy with or without a planned taxane

·         No prior use of ginkgo biloba within 6 months of study enrollment

 N03CC (05-03-292), PI: Daron Ferris, MD; MCG

A Randomizedm Controlled, Open-Label trial of Empiric Prophylactic vs. Delatyed Use of Zoledronic Acid for Prevention of Bone Loss in Postmenopausal Women with Breast Cancer Initiating Therapy with Letrozole After Tamoxifen

• Women > 55 yrs with cessation of menses
• Women  ≤ 55 yrs with spontaneous cessation of menses > 1 year
• Women ≤ 55 yrs with spontaneous cessation of menses ≤ 1 year, amenorrheic, and with postmenopausal estradiol levels
• Bilateral oophorectomy
• Stage I, II, or IIIA  localized breast cancer without evidence of recurrent, or metastatic disease
• Completed ≤ 6 yrs of adjuvant tamoxifen therapy

Breast – Other

IBCSG 24-02 (05-09-070), PI: Anand Jillella, MD; MCG & Athens

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer

•  Premenopausal Women

• Patients who did not receive chemo randomized within 12 weeks after surgery

• Patients who received prior adjuvant and/or nonadjuvant chemo randomized within 6 months after final dose (as soon as premenopausal status is confirmed)

• Hormone receptor positive tumors

Breast –Ductal Carcinoma In Situ (DCIS)

NSABP B-35 (03-02-223), PI: Anand Jillella, MD; MCG, Athens, Aiken

A Clinical Trial Comparing Anastrozole with Tamoxifen in Post-Menopausal Patients with Ductal Carcinoma in SITU (DCIS) Undergoing Lumpectomy with Radiation therapy

• Postmenopausal at time of randomization

• Tumor must be DCIS

• ER/PgR positive

• May have more than one region of DCIS as long as margins are tumor free

• Nodes are a pathetically negative

Breast – Adjuvant – Node Negative

CALGB 40101 (03-10-118), PI: Anand Jillella, MD; MCG

Cyclophosphamide and Doxorubicin (CA 4 vs 6 cycles) as Adjuvant Therapy for Women with Node-Negative Breast Cancer:  A 2x2 Factorial Phase III Randomized Study

• invasive carcinoma w/negative axillary lymph node
• must have “high risk,”  tumor >= 1cm
• ER/PR negative

NSABP B-36 (04-06-418), PI: Anand Jillella, MD; MCG, Athens, Aiken

A Clinical Trial of Adjuvant therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node-Negative Breast Cancer

• Time between surgery and randomization < 84 days
• Pre and Post menopausal women eligible
• No prior Chemo/Rtx allowed

Breast – Adjuvant – Node Positive

NSABP B-38 (04-11-160), PI: Anand Jillella, MD; MCG, Athens, Aiken

A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women with Node-Positive Breast Cancer:  Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC→P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC→PG)

• Invasive Carcinoma of the Breast

• Primary tumor, T1-3

• Ipsilateral nodes, cN0, cN1, or cN2a

• Ipsilateral nodes, pN1, pN2a, pN3a, or pN3b

• Lumpectomy or Mastectomy

•  ER/PR positive or negative

Breast – Metastatic

S0226 (05-09-067), PI: Anand Jillella, MD; MCG

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer

• Patient must be postmenopausal
• ER or PgR positive
• Zubrod performance status 0-2
• Prior adjuvant or neoadjuvant chemo must have been completed at least 12 months prior to randomization

Head & Neck

E1302 (05-01-223), PI: Anand Jillella, MD; MCG, VA, Athens, Aiken

Phase III Randomized, Placebo Controlled, Trial fo Docetaxel Versus Docetaxel Plus AC1839 (Iressa, Gefitinib) in Performance Status 2 or Previously Treated patients with Recurrent or Metastatic Head and Neck Cancer

• Patients must have either:
  • ECOG performance status 2 & no prior chemotherapy
  • Prior Chemotherapy for locally recurrent/metastatic disease
• No prior therapy with Docetaxel
• No prior EGFR inhibitors

Genitourinary

S9921 (02-10-110), PI: Anand Jillella, MD; MCG, Aiken

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy: Phase III

• Prostate Clinical Stage T1-T2
• Must have had a radical Prostatectomy
• Gleasons sum ≥ 8
• Prior neodadjuvant hormonal therapy is allowed
• No prior radiation therapy allowed

Colorectal

 COLORECTAL SCREENING PROTOCOL

Fox Chase 00-841 (05-09-068), PI: Daron Ferris, MD; MCG

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

• Adenocarcinoma of the colon or rectum
• Diagnosis beginning January 1, 1999
• ≤ 60 years of age at diagnosis
• At least one living sibling (preferably 5-10 siblings J)
• Sibling must have been ≥ 40 years of age or within 10 years of age at when proband was diagnosed

A Phase III Clinical trial Comapring Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks with Bevacizumab to the Same Regimen without Bevacizumab for the Treatment of Patients with Resected Stages II and III Carcinoma of the Colon

• Tumor must be ≥ 12 cm from the anal verge
• For patients with T₄ tumors please see eligibility criteria in protocol (page 19, 5.1.7)
• ECOG performance status 0-1

 NSABP R-04 (04-10-141), PI: Anand Jillella, MD; MCG, Athens, Aiken

A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum

• Invasive rectal cancer obtained by incisional biopsy

• Tumor distal border < 12 cm from anal verge

• Stage II or III

• Measurable disease

• Zubrod performance status 0, 1, or 2

Renal

E6800 (04-11-159), PI: Anand Jillella, MD; MCG, VA, Athens, Aiken

A Phase II Trial Evaluating Atrasentan in Patients with Advanced Renal Cell Carcinoma

• One and only one prior regimen of immunotherapy
  Patients may have had prior biphosphonate therapy

• Patients may have had prior nephrectomy

• No prior radiation therapy for target lesion

Pancreatic

CALGB 80303 (05-06-389), PI: Anand Jillella, MD; MCG, Athens

A Randomized Phase III Trial of Gemcitabine Plus Bevacizumab (NSC #704865 IND #7921) Versus Gemcitabine Plus Placebo in Patients with Advanced Pancreatic Cancer

• No prior chemo for metastatic disease
• No prior treatment with Gemcitabine/Bevacizumab in the adjuvant or metastatic setting, or prior therapy with VEGF inhibitors
• > 4 weeks from administration of the last dose of adjuvant chemotherapy. The patients must have recovered from all treatment related toxicities and must have evidence of disease progression following adjuvant treatment
• ECOG performance status of 0, 1, or 2

Melanoma

E1697 (99-09-049), PI: Anand Jillella, MD; MCG

Randomized Study of Four Weeks high Dose IFN-Alpha 2b in Stage II-A Melanoma

• Melanoma of cutaneous origin are eligible
• Initial presentation of melanoma are eligible
• No clinical palpable lymphadenopathy
• T₃N₀M₀, T₄N₀M₀, or T_1-4N₁
• Patients must have undergone an adequate wide excision of the primary lesion

E4697 (00-03-220), PI: Anand Jillella, MD; MCG

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with “No evidence of Disease” after Complete Surgical Resection of “Locally Advanced” and/or Stage IV Melanoma

·         Completely resected disease with one of the following:

o        Any locoregional recurrence after prior adjuvant interferon or failure on S0008

o        Any local recurrence of disease after adequate surgical excision of the original primary

o        Mucosal Melanoma

o        Stage IV Melanoma (cutaneous, ocular, mucosal, or unknown primary)

·         Previous radiation therapy after resection is allowed

·         No prior treatment with GM-CSF

Respiratory (Lung)

Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer

• ≥ 18 years of age
• Undergone complete resection of a histologically proven stage 1A or Stage 1B non-small cell lung cancer who are currently cured of disease
• Between 6 months and 36 months from date of surgical resection
• Excluding patients with synchronous lesions (lung + non-lung) or metastasis, even if respectable.  No history of greater than one lung cancer primary at any time

E3598 (00-05-271), PI: Anand Jillella, MD; MCG, VA, Aiken

A Phase III Trial of Carboplatin, Paclitaxel, and Thoracic Radiotherapy with or without Thalidomide in Patients with Stage III NSCLC

• Unresectable Stage IIIA or IIIB NSCLC without significant pleural effusion
• Newly diagnosed non-small cell bronchogenic carcinoma
• No prior chemo or radiation therapy

Genetic Mapping

ECOG Laboratory Study:  Mapping Interactive Cancer Susceptability Loci

• Sibling Study
• The patient must have pathologically confirmed cancer of the breast, prostate, lung, or colon
• The sibling of the patient must have (or have had) cancer of the same type
• Patients affected sibling must be available for genetic typing & be a natural full sibling

Symptom Management

The Use of Valeriana Officinalis (Valerian) in Improving Sleep in

Patients Who Are Undergoing Adjuvant Treatment for Cancer:  A

Phase III Randomized, Placebo-Controlled, Double Blind Study

·         18 years of age or older

·         Diagnosed with cancer receiving radiation, chemotherapy,

       or hormone therapy

·         Having difficulty sleeping and would like

        therapeutic intervention

·         On scale of 0-10 (10 being worse) must have a score over

Three

·         No prior use of Valerian or other sleep medications

·         Exclude patients with obstructive sleep apnea

The Efficacy of Lidocaine Patch in the Management of Postsurgical Neuropathic Pain in Patients with Cancer:  A Phase III Double-Blind,

Crossover Study

• 18 years of age or older
• Surgical procedure as part of cancer diagnosis or treatment ≥ 1 month ago and now experiencing persistent pain with neuropathic features
• Pain that is anatomically related to the surgical site and compatible with nerve injury
• Pain rating ≥ 4 out of 10
• No use of topical medications ≤ 7 days prior to study entry on the affected area

N02C4 (05-02-251), PI: Daron Ferris, MD; MCG

Phase III Double-Blind, Placebo-Controlled Randomized

Comparison of Creatinine for Cancer-Associated Weight Loss

·         18 years of age or older

·         Histologic or cytologic proven cancer other than primary

brain cancer

·         Have lost ≥ 5 pounds in ≤ 2 months and/or have an

        estimated Caloric intake of 20 cal/kg daily

·        Determination by attending physician that weight gain

Would be beneficial

       Other Helpful Resources:

American Cancer Society

Young Survival Coalition

Leukemia & Lymphoma Society

US TOO (A Prostate Cancer Education & Support Group)
 

Copyright
Medical College of Georgia
All rights reserved.

Department of Medicine | Medical College of Georgia
Please email questions and comments to:

June 08, 2007