Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Chugai Pharmaceutical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Capecitabine; Drug: Bevacizumab; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345761

JO19380

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

Step 1

Experimental group

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin

Step 2

Experimental group

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Bevacizumab

Step 3

Experimental group

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Bevacizumab