List All Colorectal Cancer Trials

Colorectal Cancer

MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
A Phase II, Multicenter, Open-Label, Randomized Study Evaluating The Efficacy And Safety Of Folfiri + Mehd7945a Versus Folfiri + Cetuximab In Second Line In Patients With Kras Wild-Type Metastatic Colorectal Cancer
Status Conditions Phase Study ID
Closed Colorectal Cancer Phase II 20121026

This open-label, randomized, multicenter Phase II study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI chemotherapy as compared to cetuximab plus FOLFIRI in patients with KRAS wild-type metastatic colorectal cancer who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Patients will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A (1100 mg intravenously every 2 weeks) or cetuximab (400mg/m2 iv loading dose Day 1 Cycle 1, followed by 250 mg/m2 iv every week). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Andrew Coveler, MD
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with KRAS wild-type status
  • Progressive disease on or after first-line oxaliplatin-containing regimen for metastatic colorectal cancer; patients must have received oxaliplatin-containing chemotherapy for >/= 3 months; no more than one prior chemotherapy for metastatic disease is allowed
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic and end-organ function
Exclusions (conditions that would prevent participation in this study)
  • Prior treatment with irinotecan
  • Prior treatment with an investigational or approved HER-targeted agent
  • Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1, including chemotherapy, biologic, experimental, hormonal or radiotherapy, or not having recovered from all treatment-related toxicities (except for alopecia) to Grade
  • Leptomeningeal disease as the only manifestation of the current malignancy
  • Active infection requiring IV antibiotics
  • Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
  • Current severe , uncontrolled systemic disease
  • History of cardiac heart failure or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)
  • History of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of unstable angina
  • Clinically significant GI bleeding within 6 months prior to Cycle 1 Day 1
  • History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of treatment
  • Known HIV infection
  • Untreated CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
  • Pregnant or lactating women
  • Malignancies other than colorectal cancer within 5 years prior to randomization, except for adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
Last Updated
December 03, 2013
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Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.