Colorectal Cancer Clinical Trial
Official title:
A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum
RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor
cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in
treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma
(cancer).
OBJECTIVES:
Primary
- Determine the objective tumor response rate in patients with progressive locally
advanced or metastatic adenocarcinoma of the colon or rectum treated with DJ-927 as
second-line treatment.
Secondary
- Determine the duration of response in patients treated with this drug.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival time in patients treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these
patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
prior first-line treatment regimen (irinotecan-containing vs oxaliplatin-containing).
Patients receive oral DJ-927* on day 1. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
NOTE: *Patients receive 1 of 2 selected doses to confirm the previously established maximum
tolerated dose
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 56-62 patients (28-31 per stratum) will be accrued for this
study within 12 months.
;
Masking: Open Label, Primary Purpose: Treatment
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