Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


SCCA at EvergreenHealth

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
NCT01652482
Summary

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.


Investigator
Andrew Coveler, MD
Location    
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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • 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.