Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

NCT ID: NCT00345761

Last Updated: 2010-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-07-31

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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Step 1

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)

Capecitabine

Intervention Type DRUG

2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Step 2

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)

Oxaliplatin

Intervention Type DRUG

130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)

Capecitabine

Intervention Type DRUG

2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Step 3

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)

Oxaliplatin

Intervention Type DRUG

130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)

Capecitabine

Intervention Type DRUG

2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Interventions

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Bevacizumab

7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)

Intervention Type DRUG

Oxaliplatin

130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)

Intervention Type DRUG

Capecitabine

2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yakult Honsha Co., LTD

INDUSTRY

Sponsor Role collaborator

Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Chugai Pharmaceutical CO.,LTD

Principal Investigators

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Yuji Hayashi

Role: STUDY_CHAIR

Clinical Development Department 3, Group 6

Locations

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Hokkaido Region

Hokkaido, Hokkaido, Japan

Site Status

Kanto Region

Kanto, Kanto, Japan

Site Status

Kinki Region

Kinki, Kinki, Japan

Site Status

Tokai Region

Tōkai, Tokai, Japan

Site Status

Countries

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Japan

Other Identifiers

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JO19380

Identifier Type: -

Identifier Source: org_study_id

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