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Two new trials enrolling patients with rectal cancer and solid tumors

Published Date
Author Earle A. Chiles Research Institute

Treating patients with stage II or III rectal cancer requires a multifaceted approach that mostly includes chemotherapy and radiation (chemoradiotherapy) to shrink tumors, followed by surgery. In some cases, the order of treatments may vary depending on where the cancer is located and whether it has spread. Some patients only receive chemotherapy and radiation to control the growth of cancer if it has advanced or if surgery isn’t an option. 

Evaluating efficacy of chemotherapy regimens 

A phase II clinical trial offered by Earle A. Chiles Research Institute, a division of Providence Cancer Institute, will test FOLFOX or CAPOX versus FOLFIRINOX in patients with locally advanced stage II or III rectal cancer.  

The purpose is to determine whether the addition of irinotecan to standard chemotherapy (FOLFIRINOX) improves outcomes. Irinotecan interferes with the growth and spread of cancer cells in the body and is used to treat cancers of the colon and rectum.  

Known as JANUS, this trial is for patients who have not received systemic chemotherapy, targeted therapy or immunotherapy, or radiation therapy for colorectal cancer within the past five years. 

Patients in this two-arm study are given long-course chemoradiation therapy and either:  

  • FOLFOX (leucovorin, fluorouracil and oxaliplatin) or CAPOX (capecitabine by mouth and oxaliplatin); or 

  • FOLFIRINOX (leucovorin, fluorouracil, irinotecan and oxaliplatin) 

FOLFOX and CAPOX regimens are used after chemoradiation as a common treatment for rectal cancer. Researchers will evaluate whether FOLFIRINOX after chemoradiation increases the response rate and leads to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX.   

This trial is offered to patients with advanced rectal cancer at multiple Providence sites in Oregon. Gina Vaccaro, M.D., medical director of Gastrointestinal Cancer Research at Providence Cancer Institute is the principal investigator.  

Learn more about this trial: 

The JANUS Rectal Cancer Trial: A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer 

Adoptive cell therapy for solid tumors evaluated in new study 

A new phase I trial will evaluate the safety and tolerability of an autologous tumor infiltrating lymphocyte (TIL) therapy called TBio-4101 in patients with advanced solid tumors. Providence Cancer Institute is the only site in Oregon currently enrolling patients. 

Employing TILs as a therapy for treating cancer is called adoptive cell therapy. Although still experimental, adoptive cell therapy is being tested in studies to treat cancers that have failed to respond to standard treatment options. 

Expanding the number of TILs to destroy cancer 

Lymphocytes are an important part of the immune system that help the body fight off infections or diseased cells. When cancer is present in the body, TILs recognize them as destructive invaders and attempt to penetrate the tumor.  

There are two ways TILs can be used as a therapy to fight cancer cells – by expanding their numbers to boost the immune response in the body or engineering them with certain attributes that enhance their ability to destroy cancer cells.  

Three tumor types evaluated in STARLING 

In this trial, known as STARLING, TILs are selected, removed from a patient’s tumor, expanded in number and then reintroduced into the patient with interleukin-2 (IL-2) after they have received chemotherapy. Following infusion, patients will receive pembrolizumab every three weeks for up to two years. 

The three arms of this trial represent the three solid tumor types to be treated with TBio-4101 and pembrolizumab: 

  • Breast cancer: Patients with locally advanced or metastatic breast cancer who were unresponsive to or intolerant of standard of care therapies. (Includes HER2+, HER 2- and TNBC.) 

  • Colorectal carcinoma: Patients with advanced, metastatic colorectal adenocarcinoma who were unresponsive to or are intolerant of at least one line of therapy that included either irinotecan or oxaliplatin. 

  • Uveal melanoma: Patients with advanced, metastatic uveal melanoma. 

The principal investigator of this study at Providence Cancer Institute is Matthew Taylor, M.D., co-medical director, Providence Melanoma Program, and medical director, Providence Thyroid Cancer Program. This study is currently enrolling patients.  

Learn more about STARLING: 

A Study of TBio-4101 (TIL) and Pembrolizumab in Patients with Advanced Solid Tumors 

How to refer a patient  

To refer a patient to one of these clinical trials:  

New research studies are added frequently. To see more clinical studies, visit:   

Providence Center of Excellence  

Since 1993, cancer research has been the primary focus of the Earle A. Chiles Research Institute, the research arm of Providence Cancer Institute of Oregon. Under the leadership of Walter J. Urba, M.D., Ph.D., our team of physicians and scientists work together to improve cancer treatment methods – seamlessly joining lab research and clinical trials with medical practice.  

 Our main area of research is cancer immunotherapy, and with the advancements in genomic sequencing, we are bringing together the power of immunotherapy and personalized medicine to accelerate leading-edge research and groundbreaking discoveries for patients with cancer.  

Learn more about the latest research and clinical trials at the Earle A. Chiles Research Institute. 

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