In cancer research, a clinical trial is a study conducted with cancer patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help cancer patients.
The search for good cancer treatments begins with basic research in laboratory and animal studies. The best results of that research are tried in patient studies, hopefully leading to findings that may help many people. The USA Mitchell Cancer Institute conducts basic and translational research with the goal of advancing cancer treatment for its patients.
Before a new treatment is provided to patients, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. But this early research cannot predict exactly how a new treatment will work with patients.
With any new treatment there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more and more information is gained about a new treatment, its risks, and how well it may or may not work.
Standard treatments, the ones now being used, are often the base for building new, hopefully better treatments. Many new treatments are designed on the basis of what has worked in the past, in efforts to improve on this.
Only patients who wish to, take part in a clinical trial. You may be interested in or asked to enter a trial. Learn as much as you can about the trial, before you make up your mind.
Why Would a Patient Be Interested in a Clinical Trial?
Patients take part in clinical trials for many reasons. Usually, they hope for benefits for themselves. They may hope for a cure of disease, a longer time to live, and a way to feel better. Often they want to contribute to a research effort that may help others.
Based on what researchers learn from laboratory studies, and sometimes earlier clinical studies and standard treatments as well, they design a trial to see if a new treatment will improve on current treatments. The hope is that it will. Often researchers use standard treatments as the building blocks to design better treatments. Researchers involved in a study have reason to believe that it will be as good as, or better than, current treatments.
The patients in a clinical trial are among the first to receive new research treatments before they are widely available. The patients who take part in clinical trial procedures that do prove to be better treatments have the first chance to benefit from them. All patients in clinical trials are carefully monitored during a trial and followed afterwards. They become part of a network of clinical trials carried out around the country. In this network, doctors and researchers pool their ideas and experience to design and monitor clinical studies. They share their knowledge from many specialties about cancer treatment and care. Patients in these studies receive the benefit of their expertise.
Clinical Trials Available at MCI
Breast Cancer
ECOG 2108 - A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Investigator: Windy Dean-Colomb, MD, PhD
http://clinicaltrials.gov/ct2/show/NCT01242800?term=value+of+early+local+therapy+for+the+intact+primary+tumor+metastatic+breast&rank=1
ECOG 3108 - A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen
Investigator: Windy Dean-Colomb, MD, PhD
http://clinicaltrials.gov/ct2/show/NCT01124695?term=single+agent+tamoxifen&recr=Open&rank=1
Cervical Cancer
GOG 240 - A Randomized Phase III Trial of Cisplatin Plus Paclitaxel with and without NCI-supplied Bevacizumab versus the non-platinum doublet, Topotecan plus Paclitaxel, with and without NCI-supplied Bevacizumab in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
Investigator: Rodney Rocconi, MD
http://www.clinicaltrials.gov/ct2/show/NCT00803062?term=GOG+and+cisplatin&recr=Open&rank=2
Endometrial Cancer
GOG 249 - A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Cancer
Investigator: Rodney Rocconi, MD
http://www.clinicaltrials.gov/ct2/show/NCT00807768?term=GOG+and+brachytherapy&recr=Open&rank=1
GOG 258 - A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
Investigator: Rodney Rocconi, MD
http://www.clinicaltrials.gov/ct2/show/NCT00942357?term=GOG+and+cisplatin+and+endometrial&recr=Open&rank=1
CTKI258A2211 - A phase II, open-label, single-arm, non-randomized, multicenter study to evaluate the efficacy of oral TAKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer
Investigator: Rodney Rocconi, MD
http://clinicaltrials.gov/ct2/show/NCT01379534?term=tki258&recr=Open&rank=2
Liver
ECOG 1208 - A Phase III Randomized Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion
Investigator: William Taylor, MD
http://www.clinicaltrials.gov/ct2/show/NCT01004978?term=ECOG+1208&rank=1
Lung
A7471009 - A Randomized Double Blind Phase 3 Efficacy and Safety Study of PF-00299804 Versus Erlotinib for the Treatment of Advanced Non-Small Cell Lung Cancer Following Progression After, or Intolerance to, at Least One Prior Chemotherapy
Investigator: Thomas Butler, MD
http://clinicaltrials.gov/ct2/show/NCT01360554?term=PF-00299804&recr=Open&rank=3
MO22097 - An Open-Label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After First (1st)-Line Treatment with Bevacizumab Plus a Platinum Doublet-Containing Chemotherapy
Investigator: Daniel Cameron, MD
http://clinicaltrials.gov/ct2/show/NCT01351415?term=MO22097&rank=1
Ovarian Cancer
GOG 252 - A Phase III Clinical Trial of Bevacizumab with IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Investigator: Rodney Rocconi, MD
http://www.clinicaltrials.gov/ct2/show/NCT00951496?term=GOG+and+ovarian+and+bevacizumab&recr=Open&rank=1
GOG 261 - A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary
Investigator: Rodney Rocconi, MD
http://clinicaltrials.gov/ct2/show/NCT00954174?term=carcinosarcoma&recr=Open&rank=2
GOG 262 - A Randomized Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin with or Without Concurrent and Consolidation Bevacizumab (NSC #704865, IND #7921) in the Treatment of Primary Stage II, III, or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer
Investigator: Rodney Rocconi, MD
http://clinicaltrials.gov/ct2/show/NCT01167712?term=ovarian+paclitaxel&recr=Open&rank=9
Pancreatic Cancer
NewLink Pancreatic Immunotherapy (NLG-0405) - A Phase II Study of Chemotherapy and Chemoradiotherapy with or without HyperAcute®-Pancreas Immunotherapy in Subjects with Surgically Resected Pancreatic Cancer
Investigator: William Taylor, MD
http://www.clinicaltrials.gov/ct2/show/NCT01072981?term=NLG+0405&rank=1
Rectal Cancer
Molecular Predictors and Prognosticators of Response to Neoadjuvant Therapy for Rectal Cancer
PI: Suzanne Russo, MD
Quality of Life in Cancer Patients
ChemoFX - Observational Study: A non-interventional, longitudinal, multi-center initiative examining outcomes associated with the use of the ChemoFX Assay® in solid tumor malignancies
Investigator: Rodney Rocconi, MD
http://www.clinicaltrials.gov/ct2/show/NCT00669422?term=PT-206&rank=1
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