A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

1. Patient has histologically or cytologically confirmed colorectal cancer.
2. Patient has at least one measurable lesion greater than or equal to 15 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 as verified by previous radiologic scans.
Note: Failing oxaliplatin would include failure due to toxicities.
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 in the summary of laboratory values, Protocol pag. 23, number 6.
7. Female patient of childbearing potential has a negative serum or urine *-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 (recent or remote) tumor available for analysis for biomarker studies.
10. Patient has a wtKRAS metastatic colorectal cancer determined by (1) testing at the program central laboratory during the screening period as outlined in the MK0646-004 Assay Charter; or (2) a documented history that the colorectal cancer was determined to be *wtKRAS* by a test conducted at a local laboratory in the period between first diagnosis and consideration for enrollment in the study (see Protocol, page section 3.1.4.1.1)

Exclusion Criteria

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, or who is within 3 weeks from a prior surgery.
2. The patient has colorectal cancer whose tumors contain an activating KRAS mutation.
3. Patient has experienced intolerable toxicity to irinotecan therapy.
4. Patient is < 18 years.
5. Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
6. Patient has known active Hepatitis B or C.
7. Patient is pregnant or breastfeeding, or expecting to conceive or father children within
the projected duration of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To determine overall survival of patients with metastatic colorectal cancer<br /><br>expressing the wtKRAS genotype treated with the combination of MK-0646,<br /><br>cetuximab, and irinotecan compared to patients treated with cetuximab and<br /><br>irinotecan alone.<br /><br><br /><br>2. To evaluate progression-free survival of patients with metastatic colorectal<br /><br>cancer expressing the wtKRAS genotype treated with the combination of MK-0646,<br /><br>cetuximab, and irinotecan compared to patients treated with cetuximab and<br /><br>irinotecan alone.<br /><br><br /><br>3. To assess the safety profile of MK-0646 of patients with metastatic<br /><br>colorectal cancer expressing the wtKRAS genotype treated with the combination<br /><br>of MK-0646, cetuximab, and irinotecan compared to patients treated with<br /><br>cetuximab and irinotecan alone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To evaluate the objective response rate of patients with metastatic<br /><br>colorectal cancer expressing the wtKRAS genotype treated with the combination<br /><br>of MK-0646, cetuximab and irinotecan compared to patients treated with<br /><br>cetuximab and irinotecan alone.</p><br>

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