A Study to Determine the Activity of SCH 717454 in Subjects With Relapsed or Recurrent Colorectal Cancer (Study P04721AM1)(COMPLETED)

• Assess Safety and tolerability of SCH 717454. [ Time Frame: Until discontinuation of SCH 717454. ] [ Designated as safety issue: Yes ]
• Tumor response rate, duration of response, and tumor growth rate. [ Time Frame: Until disease progression. ] [ Designated as safety issue: No ]

• Assess Safety and tolerability of SCH 717454. [ Time Frame: Until discontinuation of SCH 717454. ]
• Tumor response rate, duration of response, and tumor growth rate. [ Time Frame: Until disease progression. ]

The purpose of this study is to determine the activity of SCH 717454 in patients with relapsed or recurrent colorectal cancer.

It will be a randomized, fixed-sequence, open-label study in patients with diagnosis of relapsed or recurrent colorectal cancer to assess response, duration of response, safety and tolerability of SCH 717454.

• Drug: SCH 717454
  SCH 717454 will be administered intravenously once every two weeks until disease progression.
• Drug: Chemotherapy and SCH 717454
  One cycle of chemotherapy currently approved and available on the market for use in colorectal cancer followed by SCH 717454.

• Experimental: SCH 717454
  SCH 717454
  Intervention: Drug: SCH 717454
• Active Comparator: Chemotherapy followed by SCH 717454.
  Chemotherapy followed by SCH 717454
  Intervention: Drug: Chemotherapy and SCH 717454

Inclusion Criteria:

• Older than 18 years of age, of any race, and gender;
• Diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that has progressed on at least first-line therapy;
• Must have a CT or MRI scan performed at some point during their immediate prior treatment or observation in order to determine tumor growth rate;
• Must have measurable disease on a CT or MRI study, performed during Screening;
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2 and a minimum life expectancy of ≥4 months;
• Must have adequate organ function within 3 weeks prior to treatment assignment

Exclusion Criteria:

• History of another malignancy;
• Known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion;
• Surgery within 3 weeks;
• Radiation therapy within 6 weeks;
• A history of uncontrolled diabetes mellitus, defined as a hemoglobin A1C of >7.5% in a patient with known diabetes mellitus;
• A recent myocardial infarction (within the past year); or a subject who at the time of Screening presents with unstable or uncontrolled angina, New York Heart Association Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram abnormality;
• An active infection;
• A subject with clinically significant hepatitis at Screening, or a subject that is hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus seropositive.