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Cancer Care Clinical Trials
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P: (401) 729-2225
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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.
Cancer Research

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: Clinical Trials Support Unit

Lung Cancer

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

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

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

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

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: Cancer and Leukemia Group B

Title: FOLFOX-A for Metastatic/Advanced Pancreatic Cancer
Phase: III
Modality: Chemotherapy
Sponsor: Brown University Oncology Group

Title: Cabazitaxel/Prednisone 20mg vx Cabazitaxel/Prednisone 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: Roger Williams Medical Center

Title: Ofatumumab or Velcade following Rituximab for Low Grade NHL Relapse
Phase: III
Modality: Immunotherapy
Sponsor: Brown University Oncology GroupĀ 

Head and Neck Cancer

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

Other Cancer Studies

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: Brown University Oncology Group