Cancer Clinical Trials

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You can also contact our Clinical Trials staff at 203.358.8879.

Our mission is to provide a broad range of high-quality studies focused on the needs of our communities. The team at Bennett Cancer Center gives you the opportunity to participate in the same studies as those found at the nation’s major cancer centers, but right here at home.

Clinical trials are research studies that test new cancer drugs, treatments, diagnostic procedures and therapies on humans. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. These studies follow pre-defined protocols that help doctors find ways to improve health and cancer care. New therapies are tested on people only after laboratory and animal studies show promising results.

Carefully conducted clinical trials are the fastest and safest way to find treatments that work. Clinical trials are strictly monitored and carefully evaluated. Your oncologist and the highly skilled physicians at Stamford Health will help you determine if you should participate in a clinical trial.

We offer National Cancer Institute trials, pharmaceutical studies and protocols written by our very own researchers. This gives you access to many leading edge chemotherapy, biotherapy, and immunotherapy treatments. We also believe in supplying you with personalized precision medicine with studies that look at prevention and treatment based on the special, even unique, characteristics of your genes.

The Stamford Health Bennett Cancer Center is accredited by the American College of Surgeons’ Commission on Cancer as an Academic Comprehensive Cancer Program and has received the Outstanding Achievement Award in the last two survey cycles. The hospital is also a long standing member of the Eastern Cooperative Oncology Group (ECOG).

PHASES

Before any medicine is made available to the public, it must undergo a clinical trial. Clinical research consists of four phases:

  • Phase I trials evaluate how a new drug should be given, how often the drug should be given, and amounts for a safe dosage. A Phase I trial usually enrolls only a small number of patients.
  • Phase II trials continue to test the safety of the drug, and begin to evaluate how well the new drug works, generally on a particular kind of cancer. In a Phase II trial, the study drug or treatment is given to larger groups of people (100-300).
  • Phase III clinical trials compare standard treatments in combination with and without a new drug. In a Phase III trial, the study drug is given to large groups of people (1,000-3,000) to: confirm its effectiveness; monitor side effects; compare it to commonly used treatments; and collect information that will allow the drug or treatment to be used safely. The time frame for this phase usually is several years.
  • Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about its side effects in various populations and any side effects associated with long-term use.

TYPES

Therapeutic trials

Therapeutic trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials seek the best way to prevent cancer in people who have never had cancer or prevent cancer from returning or a new cancer occurring in people who have already had cancer.

Screening trials

Screening trials test the best way to find cancer, especially in its early stages.

Quality of Life trials

Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for cancer patients.

JOINING

All clinical trials have have specific guidelines such as age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study. The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. Whether you participate in a clinical trial or not is ultimately your choice. By discussing all of your options with your oncologist and our cancer care team, you will be better able to make a decision that is right for your unique situation.

Questions to Consider

  • What is the purpose of the study?
  • What kinds of tests and treatments does the study involve?
  • What does the treatment do?
  • Has the treatment been used before? Has it been used for other types of cancers?
  • Will I know which treatment I receive?
  • What are my other choices?
  • How is this going to benefit me?
  • What are the potential risks?
  • What side effects can I expect from the study? Can the side effects be controlled?
  • What are my responsibilities if I participate?
  • Will the study cost me anything? Will any of the treatment be free?
  • Does commercial insurance or Medicare/Medicaid cover any of the procedures of the trial?
  • If I'm harmed as a result of the research, what treatment might I get?
  • What are my rights as a participant in this study?

We currently offer specific clinical trials in:

BREAST CANCER

(203) 358-8879

ALLIANCE A011202

Helen Pass MD,

Mary Miller, LPN

NCT01901094 A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease after Neoadjuvant Chemotherapy

NSABP B-51 Helen Pass MD,,

Mary Miller, LPN

NCT01872975 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

ALLIANCE

A011401

Steve Lo, MD

Mary Miller, LPN

NCT02750826 A Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

ALLIANCE

A011502

Jamie Stratton, MD

Mary Miller, LPN

NCT02927249 A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive Her2 Negative Breast Cancer: The ABC Trial

SWOG S1207
Paul Weinstein, MD
Mary Miller, LPN

NCT01674140 Phase III Randomized, Placebo-controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk Hormone Receptor-Positive and HER2/NEU Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy

Cascadian Therapeutics ONT-380-206

K. M. Steve Lo, MD

Mary Miller, LPN

NCT02614794 A Randomized Phase II Placebo-Controlled Study of Tucatinib Versus Placebo Plus Capecitabine & Trastuzumab in Progressive Locally Advanced Unresectable or Metastatic HER2+ Breast Cancer

 DFCI #16-052

K. M. Steve Lo, MD

Mary Miller, LPN

NCT02764551 PELOPS: Palbociclib and Endocrine therapy for LObular breast cancer Preoperative Study: A randomized phase II study of Palbociclib with endocrine therapy versus endocrine therapy alone for Invasive Ductal Carcinoma

 DFCI/HCC #17-512

K. M. Steve Lo, MD

Mary Miller, LPN

NCT

currently not available

 A randomized phase II trial of carboplatin with or without nivolumab in first- or second-line metastatic triple-negative breast cancer

Toray

TRY-003B

David Gruen, MD

Juan Garcia, RN

N/A Collection Protocol for A Pilot Study: Analysis of Serum miRNA from Women Referred for Breast Biopsy with Abnormal Breast Imaging Classified as BI-RADS 4 or 5

COLON CANCER

(203) 358-8879

SWOG S0820

Salvatore
Del Prete, MD

Ed Hatton, RN

NCT01349881 A Double Blind Placebo-Controlled Trial Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III – Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)

HEMATOLOGIC MALIGNANCIES

(203) 358-8879

ALLIANCE Foundation AFT-28

Steve Lo, MD

Megha Shah

NCT02744092

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

Celgene CONNECT MDS/AML Michael Bar, MD

Megha Shah

NCT01688011

CONNECT MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Stamford Hospital HOA 2012-01

Salvatore
Del Prete, MD

Ed Hatton, RN

N/A

Incidence and Time Course of Anemia in Patients Receiving Platinum and/or Taxane-based Chemotherapy

LUNG CANCER

(203) 358-8879

ALLIANCE A151216 Salvatore
Del Prete, MD

Ed Hatton, RN

NCT02194738 Adjuvant Lung Cancer Enrichment Mark Identification and Sequencing Trial (ALCHEMIST)

ALLIANCE A081105 Salvatore
Del Prete, MD

Ed Hatton, RN

NCT02193282 Randomized, Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

EA5142

Salvatore
Del Prete, MD

Ed Hatton, RN

NCT02595944 Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) ~ A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)

E4512 Salvatore
Del Prete, MD

Ed Hatton, RN

NCT02201992 A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

iSpecimen ISPC-160817-BLOOD

Suzanne Rose, PhD

Megha Shah

 

N/A

iSpecimen Network Protocol: "Collection and Distribution of Minimal Risk and Higher Volume Blood Biospecimens for Novel Research Uses."

Project 1073: NSCLC Plasma: K2EDTA 8-10ml of plasma from up to 100 unique donors with late stage (Stage III/IV by AJCC or UICC) non-small cell lung carcinoma (NSCLC) adenocarcinoma. Donors must be confirmed negative for EGFR at the time of collection

MELANOMA

(203) 358-8879

ECOG-ACRIN EA6134

Salvatore Del Prete, MD

Ed Hatton, RN

NCT02224781 A Randomized Phase III Trial in advanced BRAFV600 Mutant Melanoma at Disease Progression of Dabrafenib + Trametinib then Ipilimumab + Nivolumab versus Ipilimumab + Nivolumab then Dabrafenib + Trametinib

MOLECULAR

(203) 358-8879

ECOG-ACRIN

EAY131

K. M. Steve Lo, MD

Mary Miller, LPN

NCT02465060 Molecular Analysis for Therapy Choice (NCI-MATCH)

TSH-SADP-2015-01

Salvatore A. Del Prete, MD

Mary Miller, LPN

N/A Tumor Genomic Analysis Registry (TOGA)

SWOG S1609

Salvatore A. Del Prete, MD

Ed Hatton, RN

NCT02834013

S1609, "DART: DUAL ANTI-CTLA-4 AND ANTI-PD-1 BLOCKADE IN RARE TUMORS”

PANCREATIC CANCER

(203) 358-8879

HALOZYME HALO-109-301 Salvatore
Del Prete, MD

Ed Hatton, RN

NCT02715804

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

PROSTATE CANCER

(203) 358-8879

Astellas ONC-MA-1004

Anthony Gulati, MD

Ed Hatton, RN

NCT02380274 A Prospective Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (TRUMPET)

Hoffmann-LaRoche

CO39385

Anthony Gulati, MD

Ed Hatton, RN

NCT03016312 A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-Pd-L1 Antibody) In Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of An Androgen Synthesis Inhibitor And Failure Of, Ineligibility For, Or Refusal Of A Taxane Regimen