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Sponsored by: |
Daiichi Sankyo Inc. |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080834 |
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 | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: DJ-927 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, 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 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
At least 1 measurable lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy
Surgery
Other
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 |
Study ID Numbers: | CDR0000356034, DAIICHI-927A-PRT004, MDA-2003-0749 |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00080834 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer recurrent rectal cancer |
stage III colon cancer stage IV colon cancer stage III rectal cancer stage IV rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
Rectal neoplasm Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |