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Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220116
First received: September 19, 2005
Last updated: January 5, 2010
Last verified: January 2010
History of Changes

September 19, 2005
January 5, 2010
August 2002
Not Provided
Objective response rates
Same as current
Complete list of historical versions of study NCT00220116 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer
A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.

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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: Capecitabine, Oxaliplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
Not Provided
Not Provided

Inclusion Criteria:

  • Age >18
  • Histologically proven colorectal adenocarcinoma, requiring therapy as defined by one of the four treatment subgroups
  • No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
  • Unidimensional measurable disease as assessed by CT. (Unless adjuvant therapy only)
  • Adequate bone marrow function; Hb >10g/dl, platelets >100 x109/l, WBC >3x109/l, Neut >1.5x109/l.
  • Adequate liver function: Serum Bilirubin <1.5 x upper limit of institutional normal
  • Adequate renal function, calculated Creatinine Clearance >50mls/min
  • No concurrent uncontrolled medical conditions
  • WHO performance status 0,1 or 2
  • Adequate contraceptive precautions, if appropriate
  • Informed written consent
  • Negative pregnancy test in women of child bearing age
  • Life expectancy > 3 months

Exclusion Criteria:

  • Medical or psychiatric condition that comprise the patient's ability to take informed consent.
  • Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months.
  • Patients with any significant symptoms or history of peripheral neuropathy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00220116
2147
No
Jane Lawrence, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP