Status:
COMPLETED
Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 adju...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00220116
Start Date
August 1 2002
Last Update
January 6 2010
Active Locations (1)
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1
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT