Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 441 for:    colon cancer AND Capecitabine

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

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: NCT00220116
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 6, 2010
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE September 19, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 6, 2010
Study Start Date  ICMJE August 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
Objective response rates
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00220116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer
Official Title  ICMJE A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.
Brief 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Capecitabine, Oxaliplatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2010)
172
Original Enrollment  ICMJE
 (submitted: September 19, 2005)
182
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00220116
Other Study ID Numbers  ICMJE 2147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane Lawrence, Royal Marsden NHS Foundation Trust
Study Sponsor  ICMJE Royal Marsden NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
PRS Account Royal Marsden NHS Foundation Trust
Verification Date January 2010

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