List All Colorectal Cancer Trials

Colorectal Cancer

Dalotuzumab + Irinotecan vs Cetuximab +Irinotecan for Metastatic Rectal Cancers (20111765)
A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels
Status Conditions Phase Study ID
Closed Colon Cancer; Rectal Cancer; Solid Tumors Phase II 20111765

The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with dalotuzumab + irinotecan therapy relative to participants treated with cetuximab + irinotecan.

Edward Lin, MD
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Metastatic colorectal cancer with primary tumor originating from the rectum
  • Available archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies
  • At least one measurable lesion greater than or equal to 10 mm
  • Disease has progressed after treatment with both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy
  • Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Exclusions (conditions that would prevent participation in this study)
  • Known diabetic who is poorly controlled
  • Chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery
  • Radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain
  • Currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study
  • Could not complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (>4 months exposure)
  • Prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors
  • Known Central Nervous System (CNS) metastases and/or carcinomatous meningitis
  • Primary CNS tumor
  • History of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma; potentially curative therapy with no evidence of that disease for 5 years, deemed low risk for recurrence by treating physician.
  • Human Immunodeficiency Virus (HIV)-positive
  • Active Hepatitis B or C receiving antiviral treatment regimens
  • Symptomatic ascites or pleural effusion
  • Concurrently using growth hormone (GH), or growth hormone inhibitors
Last Updated
June 20, 2013
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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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.