Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Study Overview
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Brief Summary
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This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Detailed Description
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This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Official Title
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Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 20-74 years of age Histologically confirmed colorectal cancer Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease At least one measurable lesion according to RECIST Exclusion Criteria: Evidence of clinically detectable ascites at study treatment start Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start. Evidence of bleeding diathesis or coagulopathy Serious, non-healing wound, ulcer, or bone fracture Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step 1<br> | Drug: Oxaliplatin<br>* 130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)<br>Drug: Capecitabine<br>* 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)<br>|
| Experimental: Step 2<br> | Drug: Bevacizumab<br>* 7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)<br>Drug: Oxaliplatin<br>* 130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)<br>Drug: Capecitabine<br>* 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)<br>|
| Experimental: Step 3<br> | Drug: Bevacizumab<br>* 7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)<br>Drug: Oxaliplatin<br>* 130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)<br>Drug: Capecitabine<br>* 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) |  | event driven | 
| Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  | event driven | 
| overall survival |  | event driven | 
| time to response |  | event driven | 
| duration of response |  | event driven | 
| concentrations of R340 and its metabolites |  | throughout study | 
| concentrations of platinum |  | throughout study | 
| concentrations of bevacizumab |  | throughout study | 
| concentrations of vascular endothelial growth factor (VEGF) |  | throughout study | 
| concentrations of anti-bevacizumab antibody |  | throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced and/or metastatic colorectal cancer