Primary Outcome Measures:
- Dose-limiting toxicity [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
- Antitumor activity [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
Intervention Details:
Drug: HuC242-DM4
Dose escalation study to define maximum tolerated dose. Doses will vary per cohort. Patients will receive an IV infusion once every three weeks.
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or metastatic colorectal cancer, pancreatic cancer, or other solid tumors.
Secondary
- Determine the qualitative and quantitative toxicities of this drug in these patients.
- Characterize the pharmacokinetics of this drug in these patients.
- Describe any antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation study.
Patients receive maytansinoid DM4-conjugated humanized monoclonal antibody huC242 IV over 4-5 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 15 patients are treated at the MTD.
Patients undergo blood collection at baseline and periodically during study for pharmacokinetic studies.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.