Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT00080834
Brief Summary:
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).
Detailed Description:
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.
Study:
NCT00080834
Study Brief:
Protocol Section:
NCT00080834