DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00080834|
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : May 16, 2012
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).
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: DJ-927||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080834
|United States, New Mexico|
|University of New Mexico Cancer Research and Treatment Center|
|Albuquerque, New Mexico, United States, 87131-5636|
|United States, Texas|
|MD Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Peter Cheverton, MD, ChB, MMED, RadT||Daiichi Pharmaceuticals|