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
|Closed||Colon Cancer; Rectal Cancer; Solid Tumors||Phase II||
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.
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 UpdatedJune 20, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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