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

Study Overview
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Brief Summary
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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

Official Title
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A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Capecitabine, Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine, Oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |