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Clinical Trials
(See key at end of page for descriptions of study sponsors)

Phases of Clinical Trials
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases:

  • Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

  • Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

  • Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide
  • In addition, after a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.


BREAST CANCER


Title: Metformin vs placebo for 5 years in early stage breast cancer (T1-3, N0/3, M0) within 12 months of completing adjuvant therapy 
Phase: III
Modality: Biological
Sponsor: CTSU

LUNG CANCER

Title: Adjuvant chemotherapy with or without Avastin for resected Stage IB-IIIA NSCLC
Phase: III
Modality: Chemotherapy and biological
Sponsor: CTSU

Title: Sunitinib or Placebo following 4 cycles of platinum based chemotherapy in Stage IIIB-IV NSCLC
Phase: III
Modality: Chemotherapy and immunotherapy
Sponsor: CALGB

Title: AVALL: Progression of Metastatic Non-Small Cell Lung Cancer on Maintenance Avastin-Continue Avastin or not? 
Phase: III
Modality: Biological
Sponsor: GenentechSWOG

Title: Stereotactic Body Radiation Therapy for consolidation after Chemotherapy/Radiation Therapy Therapy in Stage III Lung Cancer
Phase: II
Modality: Radiation Therapy
Sponsor: BeUOG

GASTROINTESTINAL/HEPATIC CANCER

Title: 6 or 12 cycles of adjuvant Folfox plus either Celecoxib or placebo for resected Stage III (note +) Colon Cancer
Phase: III
Modality: Chemotherapy
Sponsor: CALGB

Title: FOLFOX-A for Metastatic/Advanced Pancreatic Cancer
Phase:III
Modality: Chemotherapy
Sponsor: BrUOG <!--[if !supportEmptyParas]-->

Title: Cabazitaxel/Prednisone 20mg vx Cabazitaxel/Prednison 25 mg q 3 weeks for second line Metastatic Prostate Cancer 
Phase: III
Modality: Chemotherapy
Sponsor: S/A EFC

LEUKEMIA/LYMPHOMA

Title: Lab Study for AML/ALL/MDS/CML: Genetic Alterations in Hematopoietic Cells using blood and bone marrow cells
Phase: NA
Modality: Lab Study
Sponsor: RWMC

Title: Ofatumumab or Velcade following Rituximab for Low Grade NHL Relapse
Phase: III
Modality: Immunotheapy
Sponsor: BrUOG

HEAD AND NECK CANCER

Title: Eribulin Mesylate and Cetuximab for Advanced Head and Neck Cancer following one prior therapy
Phase: I
Modality: Chemotherapy
Sponsor: BrUOG

OTHER
Title: Adjuvant Ipilimumab vs Interferon for resected High-Risk Melanoma
Phase: III
Modality: Immunotherapy, Biological
Sponsor: CTSU

Title: Assessment of the effectiveness of Chemotherapy teaching
Phase: NA
Modality: Observational
Sponsor: BrUOG

Description of study sponsors:

    * BrUOG = Brown University Oncology Group
    * CALGB = Cancer and Leukemia Group B
    * CTSU = Clinical Trials Support Unit
    * IBCSG = International Breast Cancer Study Group
    * MHRI = Memorial Hospital of Rhode Island
    * NSABP = National Surgical Adjuvant Breast and Bowel Project
    * RTOG = Radiation Therapy Oncology Group
    * SWOG = Southwest Oncology Group

(Revised 6/4/13)
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