Clinical trials provide crucial information about the safety, effectiveness and proper use of new drugs, diagnostic tests and other medical procedures. They are usually done in the laboratory of an academic center or a pharmaceutical company or in the clinical setting of an academic center or private medical practice.
Clinical trials are divided in four categories or phases (I through IV):
Phase I: Drugs are given for the first time to a small group of patients. These types of trials are designed to only assess the drug’s toxic effect in humans and/or evaluate new dosage or mode of administration. Phase I studies do not determine the effectiveness of the drugs tested.
Phase II: Drugs are given to a larger group of participants to further evaluate their safety.
Phase III: Drugs are given to a larger group of participants to confirm their effectiveness, monitor side effects, and compare them to established FDA-approved treatments for that particular condition.
Phase IV: These trials are performed after the drugs have reached the mainstream patient population and are FDA-approved. Information continues to be collected to determine long-term effects.
Types of clinical trials
Treatment: Clinical trials are designed to test new drug treatments, surgical or radiation therapy approaches to prevent recurrence or progression of disease.
Prevention or risk reduction: These trials investigate novel ways to prevent disease in people who are at an increased risk of developing certain types of cancer.
Diagnostic: Trials are designed to explore better tests to diagnose disease.
Quality-of-Life: These trials explore ways to improve quality of life for individuals with a chronic illness.
Monitoring of clinical trials
Governing bodies made up of physicians, representatives of institutions and the lay public as well as state and federal officials closely monitor every stage of the trial. This is done to ensure the safety of the participants as well as the integrity of the information being collected. All drugs are approved by the FDA before they are administered to the public.
Making an educated decision
Clinical trials represent an opportunity for patients to receive state-of-the-art cancer care while helping to advance knowledge about cancer treatments. The physicians at University Medical Oncology provide patients with the opportunity to actively participate in clinical trials through their affiliation with Sarah Cannon Institute, Veeda, various national and regional cooperative groups as well as pharmaceutical companies.
Benefits of enrolling in a clinical trial
- Access to drugs or new treatment not yet available to the general population.
- Participation in a clinical trial entitles patients to additional medical attention from their medical team.
- Participants know they are helping mankind develop new therapies for future generations of patients.
Possible risks of enrolling in a clinical trial
- Participants must submit to additional testing and visits to the doctor’s office to monitor their progress and/or potential side effects.
- Commitment of time, travel and to complete the clinical trial.
- Participants may not derive any benefit from the specific treatment.
- Participants may experience increased or unexpected side effects from the new treatment.
- Participants may be randomly assigned to receive a specific treatment or a placebo (nondrug substitute) treatment.
- Cost: While there are costs involved in conducting clinical trials, there is no additional cost to the participant. The sponsor of the trial and the patient’s health insurance company will cover the cost.
Enrollment in a clinical trial
All clinical trials have guidelines about who can participate in the study. Such eligibility or exclusion criteria based upon such factors as age, type of disease and stage, medical history and current medical condition.
Individuals do not have to be an active patient at University Medical Oncology to participate in any clinical trials available through our practice. Once a patient is referred by their primary care physician or oncologist, they will be under the care of one the physicians at University Medical Oncology.
Participants may leave a clinical trial at any time; however patients are encouraged to give careful consideration about their participation in the clinical trial prior to enrollment.
If the participant’s condition does not improve or even declines, due to the close monitoring, immediate measures can be taken such that the individual’s health is not compromised by the clinical trial.
The length of clinical trials varies from a few weeks to several years.
Current Clinical Trials
The following clinical trials are currently available at University Medical Oncology. This list will be updated on our website periodically; however, you may obtain more information by contacting us at 706.722.4245 and asking for our clinical trial coordinator Christie Duffie, RN.
- BRE-145 Phase III Study: A Randomized Trial of Ixempra versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer (TITAN)
- BRE-133 Phase II Study: Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer
- BRE-139 Phase II Study: Neoadjuvant Ixabepilone and Carboplatin plus Herceptin in HER-2 Positive Breast Cancer
- GI 135 Phase II Study: Bevacizumab, Pertuzumab and Sandostatin for Patients with Advanced Neuroendocrine Cancer
- I-07-041 Phase II Study: A Multi-center, Open-label, Randomized Study, Evaluating Safety and Efficacy of FOLFIRI with Either Panitumumab or Bevacizumab as Second-Line Treatment in Patients with Metastatic Colorectal Cancer with wild-type KRAS Tumors (SPIRITT Trial)
- V-08-043 Phase II Study: Randomized, Multi-center Study, Comparing the Efficacy of Panitumumab in Combination with mFOLFOX6 to the Efficacy of Bevacizumab in Combination with mFOLFOX6 in Patients with Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer (PEAK Trial)
- LUN 186 Phase II Study: Preoperative Pemetrexed and Carboplatin in Patients with Stage IB, II and III Non-Squamous Non-Small Cell Lung Cancer
- LUN 201 Phase III Study: Gemcitabine/Carboplatin with or without BSI-201, a PARP1 Inhibitor in Patients with Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer
- LUN 199 Phase II Study: Amrubicin and Carboplatin with Pegfilgrastim in Patients with Extensive Stage Small Cell Lung Cancer
- V-08-036 Phase III Study: Randomized, Open-Label Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer
- LUN-142 Phase II Study: Adjuvant Carboplatin, Docetaxel, Avastin and Erlotinib versus Chemotherapy alone in Patients with Resected Non-Small Cell Lung Cancer
- V-08-030 Double-Blind, Placebo Controlled Study: Evaluation of the Long Term Safety and Efficacy of Aranesp 500mcg. Once Every Three Weeks in Anemic Patients with Advanced Stage Non-Small Cell Lung Cancer Receiving Multi-Cycle Chemotherapy
Renal Cell Cancer
- GU-43 Phase II Study: High Dose Bevacizumab in the Treatment of Patients with Advanced Clear Cell Renal Carcinoma
- GU-56 Phase II Study: Pazopanib in Patients with Metastatic Renal Cell Carcinoma Previously Treated with Sunitinib or Bevacizumab
- LYM-37 Phase II Study: Rituximab with or without Bevacizumab in the Treatment of Patients with Follicular Non-Hodgkin’s Lymphoma
- V-09-030 Phase III Study: Tasisulam Administered as an Intravenous Infusion in Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma.