A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]metastatic colorectal cancerMedDRA version: 14.1Level: PTClassification code 10055114Term: Colon cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2007-001116-22-IT
- Lead Sponsor
- MSD ITALIA S.R.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
Patients must meet all of the following criteria to participate in the study: 1. Patient has histologically or cytologically confirmed colorectal cancer. 2. Patient has at least one measurable lesion greater than or equal to 20 mm. 3. Patient has previously failed both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression. 4. Patient is male or female, and ≥18 years of age on the day of signing informed consent. 5. Patient has performance status 0-1 on the ECOG Performance Scale. 6. Patient has adequate organ function as indicated by the following laboratory values: 0646, Protocol 004-00 Issue Date: 17-May-2007 16 Product: MK-0646 8 Protocol/Amendment No.: 004-00 0646_004-00_ProtCore VERSION 4.0 APPROVED 17-May-2007 Worldwide Restricted Confidential - Limited Access System Laboratory Value Hematological Absolute Neutrophil Count (ANC) ≥1,500/mcL Platelets ≥100,000/mcL Hemoglobin ≥9 g/dL-without qualifications, use of erythropoietin and transfusions are allowed Renal Serum Creatinine/calculated creatine clearancea ≤2 times the upper limit of normal (ULN)/ ≥60 mL/min (patients with creatinine levels ≥2 times the ULN). Patient may not be on dialysis. Hepatic Serum total bilirubin ≤1.5 times the ULN AST (SGOT) and ALT (SGPT) ≤5 times the ULN Coagulation Prothrombin time (PT) Partial Thromboplastin time (PTT) ≤1.2 times the ULN ≤1.2 times the ULN a Creatinine clearance should be calculated per institutional standard. 7. Female patient of childbearing potential has a negative serum or urine β-hCG pregnancy test at baseline. 8. Patient, or patient's legal representative, has voluntarily agreed to participate by giving written informed consent. 9. Patient has archival tumor available for analysis for biomarker studies.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A patient meeting any of the following criteria is not eligible to participate in this study: 1. Patient who has had chemotherapy, radiotherapy, 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. 2. Patient is 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. 3. Patient has experienced intolerable toxicity to irinotecan therapy. 4. Patient has prior exposure to IGF-1R inhibitors or EGFR inhibitors (e.g. cetuximab). 0646, Protocol 004-00 Issue Date: 17-May-2007 17 Product: MK-0646 9 Protocol/Amendment No.: 004-00 0646_004-00_ProtCore VERSION 4.0 APPROVED 17-May-2007 Worldwide Restricted Confidential - Limited Access 5. Patient has CNS metastases and/or carcinomatous meningitis. 6. Patient has primary central nervous system tumor. 7. Patient has a known hypersensitivity to the components of study drugs or its analogs that is not treatable by premedication with antihistamines and steroids. 8. Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. 9. Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician. 10. Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 11. Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse. 12. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study. 13. Patient is known to be Human Immunodeficiency Virus (HIV)-positive. 14. Patient has known active Hepatitis B or C. 15. Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible. 16. Patient is concurrently using growth hormone (GH), or growth hormone inhibitors.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To evaluate the objective response rate of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab and irinotecan compared to patients treated with cetuximab and irinotecan alone;Main Objective: 1. To determine overall survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone. 2. To evaluate progression-free survival of patients with metastatic colorectal cancer treated with the combination of MK-0646, cetuximab, and irinotecan compared to patients treated with cetuximab and irinotecan alone.;Primary end point(s): 1)survival 2)progrssion free survival
- Secondary Outcome Measures
Name Time Method