Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Hokkaido, Japan
    • Hokkaido region
  • Kanto, Japan
    • Kanto region
  • Kinki, Japan
    • Kinki region
  • Tokai, Japan
    • Tokai region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Collaborators: Yakult Honsha Co., LTD
• Investigators: Study Chair: Yuji Hayashi, Clinical Development Department 3, Group 6

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 27, 2006
• First Submitted That Met QC Criteria: June 27, 2006
• First Posted (Estimate): June 28, 2006

Study Record Updates

• Last Update Posted (Estimate): August 16, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Advanced and/or metastatic colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Capecitabine; Oxaliplatin; Bevacizumab
• Other Study ID Numbers: JO19380