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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
NCT01609231
Summary

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.


Investigator
Edward Lin, MD
Location    
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 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.