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Clinical Trials Monthly - August 2012


Colorectal Cancer

  • Molecular Markers for Colon Cancer Screening (NCT01511653)

Esophageal/Gastric Cancers

  • Ramucirumab for Gastric, Esophageal, and Gastroesophageal Cancer (NCT01246960)

Pancreatic Cancer

  • LY2157299 for Advanced or Metastatic Pancreatic Cancer (NCT01373164)
  • Combination Chemotherapy + Radiation + Surgery for Localized Pancreatic Cancer (NCT00609336)

Colorectal Cancer

Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma (NCT01511653)

Investigator: William M. Grady, MD

This is a multi-center, 6,000-subject validation study of several biomarkers for early detection of colon cancer. There are two stool-based biomarkers (one is a panel) and one serum-based biomarker being validated in this study. The results of the biomarker tests will be compared with those of the colonoscopy and fecal immunohistochemistry (FIT) tests, which are the current standards for colon cancer screening.

This project is funded by the NCI Early Detection Research Network. The population targeted for this study is people 50 to 80 years of age undergoing colonoscopy for screening or routine surveillance. If patients are interested in participating, the informed consent process will take place during a baseline visit where the stool kits will be de-scribed and given to patients to take home. Stool samples will be sent to the University of Michigan. Prior to prepping for colonoscopy, subjects will provide blood as well as specific data regarding their GI and general medical history and concomitant medications.

Esophageal/Gastric Cancers

Randomized, Placebo-Controlled, Double-Blind Phase II Study of mFOLFOX6 Chemotherapy plus Ramucirumab Drug Product (IMC-1121B) versus mFOLFOX6 plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, or Stomach (NCT01246960)

This study will determine whether ramucirumab, a monoclonal antibody that binds to vascular endothelial growth factor receptor 2, blocking angiogenesis, with chemotherapy can help patients with stomach, esophagus, and gastroesophageal cancer.

Open to SCCA Network members, confirmed adenocarcinoma patients with metastatic or locally advanced and unresectable disease at time of randomization may be enrolled.

Patients who’ve received prior first-line systemic therapy for advanced/unresectable and/or metastatic disease (prior adjuvant or neoadjuvant therapy is permitted) will be excluded.
Investigator: Andrew L. Coveler, MD

Pancreatic Cancer

A Phase Ib/II Study with Gemcitabine and LY2157299 for Patients with Metastatic Cancer (Phase Ib) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase II) (NCT01373164)

In the Phase Ib portion of this study, we hope to determine the safe and tolerable dose of LY2157299 in combination with gemcitabine in patients with a solid malignancy. LY2157299 is a selective small molecule kinase inhibitor of transforming growth factor beta receptor (TGF-ßR).

In the Phase IIa portion of the trial, we will measure the overall survival of patients with Stage II to IV unresectable pancreatic cancer, comparing outcomes in those treated with a combination of LY2157299 and gemcitabine with those treated with gemcitabine plus placebo.
Investigator: Andrew L. Coveler, MD

A Phase II Study of Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection, and Adjuvant Chemotherapy for Patients with Localized Resectable Pancreatic Adenocarcinoma (FHCRC-6511) (NCT00609336)

Standard treatment for pancreatic cancer is surgery to remove the cancer. This study will determine whether adding chemotherapy and radiation to surgery will delay (or stop) the return of pancreatic cancer. Patients with localized resectable or borderline resectable pancreatic adenocarcinoma (T1-T3, N0-N1, MO) are eligible. All patients receive the same treatment. The goal of pre-surgical treatment is to shrink the tumor that needs to be removed while post-surgical chemotherapy aims to kill any remaining tumor cells.

Completing all of the treatment on this study will take about eight to 11 months. Patients will receive chemotherapy and radiation treatments at Seattle Cancer Care Alliance. Surgery will occur at University of Washington Medical Center. The status of patients will be monitored after they are no longer receiving study treatment.
Investigator: Andrew L. Coveler, MD

Adult Bone Marrow Transplant News

The SCCA Adult Bone Marrow Transplant News is a publication presenting the latest information on bone marrow transplant research at SCCA, providing up-to-date information for all health care professionals caring for transplant patients.

Pediatric Bone Marrow Transplant News

Read about important outcomes research at the Fred Hutch that may benefit your patients.

Clinical Trials Monthly

Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.

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Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.