NCT00345761

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_1 colorectal-cancer

Timeline
Completed

Started Feb 2006

Typical duration for phase_1 colorectal-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

2.7 years

First QC Date

June 27, 2006

Last Update Submit

August 13, 2010

Conditions

Colorectal Cancer

Keywords

Advanced and/or metastatic colorectal cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (3)

Step 1

EXPERIMENTAL
Drug: OxaliplatinDrug: Capecitabine

Step 2

EXPERIMENTAL
Drug: BevacizumabDrug: OxaliplatinDrug: Capecitabine

Step 3

EXPERIMENTAL
Drug: BevacizumabDrug: OxaliplatinDrug: Capecitabine

Interventions

BevacizumabDRUG

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

Step 2Step 3
OxaliplatinDRUG

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

Step 1Step 2Step 3
CapecitabineDRUG

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

Step 1Step 2Step 3

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hokkaido Region

Hokkaido, Hokkaido, Japan

Location

Kanto Region

Kanto, Kanto, Japan

Location

Kinki Region

Kinki, Kinki, Japan

Location

Tokai Region

Tōkai, Tokai, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabOxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Yuji Hayashi

    Clinical Development Department 3, Group 6

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

February 1, 2006

Primary Completion

October 1, 2008

Study Completion

July 1, 2010

Last Updated

August 16, 2010

Record last verified: 2010-08

Locations

JP(4)