Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer
Summary
To assess the efficacy and safety of the combination of capecitabine and oxaliplatin in the 1st, 2nd or subsequent line treatment of metastatic colorectal cancer, and also in the neo-adjuvant and adjuvant setting of resectable metastases.
Primary Endpoint: Objective response rates
Secondary Endpoints: Treatment related toxicity Progression free survival (If not resected) Disease free Survival (From metastastectomy, if resected) Overall Survival 60 Day all cause mortality Number undergoing liver resections/curative resection (Ro) rate
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Intervention
Capecitabine, Oxaliplatin
Location
Royal Marsden Hospital
Sutton
Surrey
United Kingdom
SM2 5PT
Status
Completed
Source
Royal Marsden NHS Foundation Trust
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00220116
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:48:58-0400
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Medical and Biotech [MESH] Definitions
Capecitabine
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
Genes, Mcc
Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).
Genes, Dcc
Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.
Colorectal Neoplasms, Hereditary Nonpolyposis
A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.
