Hung Khong, M.D., Associate Director, Clinical Research What is a clinical trial? 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. More Resources ClinicalTrials.gov NCI's Clinical Trials Information Page NCI Cancer Trials Support Unit (CTSU) National Library of Medicine (NLM) People Living With Cancer

Clinical Trials Available at MCI

Breast Cancer

IRB # 06-233- Phase 3 study of SU011248 in combination with paclitaxel vs. bevacizumab with paclitaxel in the 1^st line setting for advanced disease in patients with breast cancer [Pfizer A6181094] – Closed to Enrollment

IRB # 06-275- Program for the Assessment of Clinical Cancer tests (PACCT-1): Trial Assigning Individualized Options for Treatment: THE TAILORX TRIAL [ECOG] http://www.clinicaltrials.gov/ct2/show/NCT00310180?term=THE+TAILORX+TRIAL&rank=1

IRB # 06-206- Randomized phase III trial comparing 16 to 18 weeks of neoadjuvant exemestane (25mg daily), letrozole (2.5mg), or anastrozole (1 mg) in postmenopausal women with clinical stage II and III estrogen receptor positive breast cancer [ACOSOG Z1031] http://www.clinicaltrials.gov/ct2/show/NCT00265759?term=ACOSOG+Z1031&rank=1 – Temporarily Closed to Enrollment

IRB # 08-157- A randomized phase III trial comparing a neoadjuvant regimen of FEC-75 followed by paclitaxel plus trastuzumab with a neoadjuvant regimen of paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab in patients with palpable and operable Breast Cancer [ACOSOG Z1041] http://www.clinicaltrials.gov/ct2/show/NCT00513292?term=ACOSOG+Z1041&rank=1

IRB # 08-116- An international multi-centre open-label 2-arm phase III trial of adjuvant bevacizumab in triple negative breast cancer [BO20289 - Beatrice] http://www.clinicaltrials.gov/ct2/show/NCT00528567?term=beatrice&rank=1

IRB # 08-136- A phase I/II clinical trial of the hypomethylating agent azacitadine (Vidaza) with the nanoparticle albumin bound paclitaxel (Abraxane) in the treatment of patients with advanced or metastatic solid tumors and breast cancer http://www.clinicaltrials.gov/ct2/show/NCT00748553?term=vast+b&rank=1

IRB # 08-220– A Phase I Study of Neoadjuvant Chemotherapy with Nanoparticle Albumin Bound Paclitaxel, Doxorubicin, and Cyclophosphamide (NAC) in Patients with Stage II and Stage III Breast Cancer PENDING

IRB # 09-004: A Phase 1/2 Open-label Study of Neratinib (HKI-272) in combination with Capecitabine in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or Locally advanced Breast Cancer [Wyeth] Enrollment begins September 2009

IRB # 09-157: A randomized, Phase III, double-blind, placebo-controlled multicenter trial of everolimus in combination with trastuzumab and paclitaxel, as first line therapy in women with her2 positive locally advanced or metastatic breast cancer

Colon/Rectal Cancer

IRB #_08-070- A randomized, phase 2B study of sunitinib plus oxaliplatin, 5-flourouracil and leucovorin (FOLFOX) versus bevacizumab plus FOLFOX as first-line treatment in patients with mestastatic colorectal cancer [A6181104] http://www.clinicaltrials.gov/ct2/show/NCT00609622?term=pfizer+colorectal+A6181104&rank=1

Endometrial Cancer

IRB # 08-069- A Phase II Study of Paclitaxel and Carboplatin in Patients with Intermediate-Risk Adenocarcinoma of the Endometrium

IRB # 09-198- A Phase III Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel Or Doxorubicin Administered Every 21 Days in Women with Advanced Endometrial Cancer Who Have Previously Been Treated with Chemotherapy

Lung Cancer

IRB # 06-276- A randomized, double-blind, phase II study of erlotinib with or without SU011248 in the treatment of metastatic non-small cell lung cancer [Pfizer A6181058] – Closed to Enrollment

IRB # 08-281- Phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (Stage IIIb/IV) non-small cell lung cancer (NSCLC) http://www.clinicaltrials.gov/ct2/show/NCT00662597?term=phase+III+asa404&rank=2

IRB # 09-251- MARGRIT 109493 A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung Cancer

Melanoma

IRB # 07-264- Phase III randomized adjuvant study of high-dose interferon a-2b (INTRON-A®) therapy in patients with Stage II or III Melanoma [ECOG-1697] http://www.clinicaltrials.gov/ct2/show/NCT00003641?term=ECOG+1697&rank=1

Ovarian Cancer

IRB # 08-282- A Phase II, Multicenter, Randomized, Double-blind, Placebo-Controlled Trial Evaluating The Efficacy and Safety of GDC-0449 as Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission http://www.clinicaltrials.gov/ct2/show/NCT00739661?term=A+Phase+II+GDC+0449&rank=1

IRB # 08-304- Phase IIb Study Evaluating the Safety and Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Second-Line Combination Gemcitabine and Platinum Therapy for Recurrent Ovarian Carcinoma http://www.clinicaltrials.gov/ct2/show/NCT00771810?term=TXA127+ovarian&rank=1

Pancreatic Cancer

IRB # 07-162- A randomized double-blind phase III study of RAD001 + best supportive care in the treatment of patients with advanced pancreatic neuroendocrine tumors [Novartis] - Closed to Enrollment

Prostate Cancer

IRB PENDING- A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined with Dasatinib to Docetaxel Combined with Placebo in Castration-Resistant Prostate Cancer.

Quality of Life

IRB # 07-034- AVF3991n: An observational study of AVASTIN® (bevacizumab) in combination with chemotherapy for treatment of metastatic or locally advanced and unresectable colorectal cancer and locally advanced or metastatic non-small cell lung cancer (excluding predominant squamous cell histology) [ARIES] (Registry Observational Study) http://www.clinicaltrials.gov/ct2/show/NCT00388206?term=aries&rank=3

IRB # 08-169- AVF4349n: An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer [VIRGO] (Registry Observational Study) http://www.clinicaltrials.gov/ct2/show/NCT00726661?term=virgo&rank=1

IRB # 08-244- ChemoFx® Observational Study: A non-interventional, longitudinal, multi-center initiative examining outcomes associated with the use of the ChemoFx Assay® in solid tumor malignancies http://www.clinicaltrials.gov/ct2/show/NCT00669422?term=chemofx&rank=1

IRB # 09-054- 3200K1-4000-WW A Randomized, Double-Blind, Placebo-Controlled Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety, and Additional HealthOutcomes http://www.clinicaltrials.gov/ct2/show/NCT00672477?term=moa+4000&rank=1

IRB # 09-053- 3200K1-4001-WW Open-Label Extension Study to Assess the Safety of a Fixed Dose of Subcutaneous Methylnaltrexone in Subjects With Advanced Illness and Opioid-Induced Constipation

Renal Cancer

IRB # 09-199- ECOG 2805 ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma