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Clinical Trials Monthly - February 2012

Clinical Trials Monthly presents new and important trials that may benefit your patients. This month we have included trials for colon and other gastrointestinal cancers, as well as an ovarian imaging study. Each study summary has a link to the specific details about the trial on our online Clinical Trials database. The complete list of all trials recruiting participants at Seattle Cancer Care Alliance can be found at

This Month’s Featured Clinical Studies

Colorectal Cancer

  • SIRT + FOLFOX for Liver Metastases from Colorectal Cancer (UW10025)
  • FOLFIRI + Ramucirumab for Metastatic Colorectal Cancer (UW10034)

GI Cancers

  • Ramucirumab for Gastric, Esophageal, and Gastroesophageal Cancer (7575)
  • Paclitaxel With or Without Ramucirumab in Metastatic Gastric Cancer (UW10036)

Ovarian Cancer

  • FDG PET for Advanced Ovarian Cancer (FHCRC-7009)

Colorectal Cancer

Randomized Comparative Study of Folfox6m Plus SIR-Spheres® Microspheres Versus Folfox6m Alone as First-Line Treatment inPatients with Non-Resectable Liver Metastases from Primary Colorectal Carcinoma (NCT00724503)

This is a first-line treatment study for patients who have colon cancer with non-resectable metastases to the liver. In the active treatment arm of the trial, a single injection of SIR-Spheres, which are microspheres containing a radioactive element, are directed to the tumor in the liver in addition to systemic chemotherapy. Currently we cannot enroll patients with Medicare in the study, but we have submitted paperwork to do this in the future. This is one of our first joint trials with University of Washington Medical Center (UWMC) Interventional Radiology, and we
have more collaborative studies with this group in the pipeline.

Investigators: Sam Whiting, MD and Siddharth Padia, MD (UWMC Interventional

Ramucirumab — Finding new ways to cure colorectal cancer

Vascular endothelial growth factor (VEGF) is over-expressed in colorectal carcinoma and considered an important part of tumor angiogenesis. Inhibiting this growth factor or its receptors is a goal for several promising targeted treatments for this deadly disease. Ramucirumab is a recombinant human monoclonal antibody that specifically binds to the outer structure of the VEGFR-2 receptor and thereby disables the related signaling pathway. This drug has been shown to be safe and well tolerated in Phase I and Phase II studies. It is being tested in several studies at SCCA as illustrated below:

A Randomized, Double-Blind, Multicenter Phase III Study of Irinotecan, Folinic Acid, and 5-fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients with Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy with Bevacizumab, Oxaliplatin, and a Fluoropyrimidine (NCT01183780)

This is a study for patients with metastatic colorectal cancer whose disease has progressed during or after first-line therapy. To be eligible for this trial, the patient must have received first-line therapy including bevacizumab, oxaliplatin, and a fluoropyrimidine. Patients will be treated once every two weeks. The infusion will include ramucirumab or placebo (double blind—neither the clinic staff nor the patient will know what the patient is getting) plus FOLFIRI (irinotecan, leucovorin, and 5FU).

Investigator: Veena Shankaran, MD

GI Cancer


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, Gastrointestinal Junction or Stomach (NCT01246960)

The purpose of this study is to determine whether ramucirumab in conjunction with chemotherapy treatment can help patients with stomach, esophageal, or gastroesophageal cancer. Eligible patients for this study have metastatic or locally advanced, unresectable disease, as well as adequate renal, hematological, and hepatic function. There are nine cycles of treatment at two-week intervals,and then a follow-up visit 30 days after the last treatment. This study is also being opened to patients through the SCCA Network.

Investigator: Sam Whiting, MD

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of Weekly Paclitaxel with or without Ramucirumab (IMC-1121B) Drug Product in Patients with Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine (NCT01170663)

This is a study for patients with metastatic stomach cancer who have failed first-line therapy with platinimum and fluoropyrimidine. Patients will be treated on Days 1, 8, and 15 on a 28-day cycle. SCCA Network physicians may refer their patients for this trial, but treatment will occur at SCCA.

Investigator: Edward Lin, MD

Ovarian Cancer

FDG PET and Biomarkers in Treatment Response in Advanced Ovarian Cancer (FHCRC-7009)

This study uses fludeoxyglucose Positron Emission Tomography (FDG PET) and selected biomarkers to determine treatment response in women with advanced ovarian cancer or primary peritoneal cancer (stage IIIC–IV). The goals of study are to determine (a) how FDG measures of glycolysis are associated with resistance to chemotherapy agents; (b) how treatment-related changes in FDG metabolic activity are associated with treatment response, disease recurrence, and disease-free interval; and (c) how specific biomarkers of tumor aggressiveness are associated with drug resistance and treatment response. Many of the biomarkers may eventually become targets for novel therapeutic agents and lead to novel therapies for ovarian cancer.

The study may directly benefit the patient, as results of the pretreatment whole body FDG-PET scan will be provided to the treating clinician. Newly diagnosed patients who have pathology-proven ovarian carcinoma or primary peritoneal cancer and who are candidates for neoadjuvant chemotherapy will have a research FDG-PET imaging scan at each of three three-hour visits to University of Washington Medical Center (prior to chemotherapy Cycle 1, after Cycle 1, and after Cycle 3). There is no additional follow-up. Treatment will not be affected by this study. The cancer treatments themselves can occur at any facility; however, patients will need to be referred to the SCCA Gynecologic Oncology Clinic to be considered for the study. This study is not open at SCCA Network sites.

Investigator: Joseph G. Rajendran, MD

Referral or Consultation

To discuss your patients’ treatment options with an SCCA physician, please call our intake office at (206) 288-SCCA (7222) or (800) 804-8824. To read the full description of each trial or enroll your patients online, please visit

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