Clinical Trials

Clinical research plays a vital role in the war on cancer.  Through research we discover new and better ways to fight this disease, improve the quality of life for patients, and ultimately one day, to prevent cancer.  Research studies, also called clinical trials or protocols, help develop better treatments to improve survival, understand how cancer grows and manage side effects of treatment to improve quality of life. 
Pearlman offers clinical trials sponsored by the National Cancer Institute as well as pharmaceutical companies.

Precision Medicine

There has been a lot of interest in recent years in refining the strategy for treating chronic or life-threatening diseases using more precise means of targeting the driver of the illness. In cancer, we’re examining the molecular environment and genetic code of tumors to identify abnormalities that can be eliminated or altered by a drug. Pearlman Cancer Center is opening a series of trials through the National Cancer Institute’s Precision Medicine Initiative that will offer patients with advanced cancers an opportunity to benefit from this innovative strategy.

The Lung-MAP Study (SWOG 1400) is the first of these trials, and it consists of several sub-studies within the larger umbrella trial. New sub-studies will be added as new potential targets are identified for exploration in squamous cell lung cancer. ALCHEMIST and the Exceptional Responders Initiative are also open. ALCHEMIST examines the usefulness of drugs that target two specific abnormalities in early stage lung cancer that has been surgically removed. Normally these drugs (erlotinib and crizotinib) are reserved for patients with more advanced disease. The Exceptional Responders Initiative is unique in that it looks back at patients who had unexpected and durable responses to treatment – what was unique about their cancers that allowed them to have such an extraordinary response? Can we exploit that finding to benefit future patients? The most recent trial to open is NCI-MATCH, which gives patients with advanced disease an opportunity to be treated with novel agents that target specific mutations or markers identified in their tumors.

This is an exciting time in cancer research as we discover how to use the unique biology of the patient’s tumor to fight these difficult cancers.

Clinical Trials: Protocols Available by Disease Site

Breast

Adjuvant

EA1131
A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy

NSABP B-55
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA 1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer who have Completed Definitive Local Treatment and Neoadjuvant or adjuvant Chemotherapy

Metastatic

SWOG 1416
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

Lung

Adjuvant

A151216
(ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial. A screening trial for A081105 and E4512.

E4512
(An ALCHEMIST sub-study) 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

A081105
(An ALCHEMIST sub-study) Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Lung Cancer (NSCLC)

EA5142
(An ALCHEMIST sub-study) 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 Cancers

Metastatic

SWOG 1400
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
 
SWOG 1403
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer

Solid Tumors

Metastatic

SWOG EAY 131 - MATCH (Molecular Analysis for Therapy Choice)
Study investigates whether tumors with mutations, amplifications or translocations in one of the genetic pathways of interest are likely to derive benefit from drugs that target that specific pathway.  Designed for patients with progressive disease or for whom no standard therapy exists.

The following disease sites have no studies available at this time: Colon, Gallbladder, Genitourinary, GIST, Head and Neck, Kidney, Leukemia, Lymphoma, Melanoma, Myeloma, and Pancreas.