NCT00065117

Brief Summary

The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

July 17, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

July 17, 2003

Last Update Submit

January 25, 2011

Conditions

Colorectal NeoplasmsMetastases, Neoplasm

Keywords

metastaticcolorectalfirst-lineadjuvantcancerColorectal CancerColorectal CarcinomaColorectal TumorsNeoplasms, Colorectal

Interventions

ZD6126DRUG
PlaceboDRUG
5-fluorouracilDRUG
leucovorinDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic colorectal carcinoma
  • Suitable for first-line treatment of metastatic disease

You may not qualify if:

  • Peripheral neuropathy greater than Grade 1
  • Adjuvant therapy within 6 months prior to study treatment
  • Prior oxaliplatin
  • Prior pelvic or whole abdomen radiation
  • Any history of coronary angioplasty or history of myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Los Angeles, California, United States

Location

Research Site

San Francisco, California, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

New Orleans, Louisiana, United States

Location

Research Site

Baltimore, Maryland, United States

Location

Research Site

St Louis, Missouri, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Chapel Hill, North Carolina, United States

Location

Research Site

Durham, North Carolina, United States

Location

Research Site

Pittsburgh, Pennsylvania, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisNeoplasms

Interventions

N-acetylcochinol-O-phosphateFluorouracilLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2003

First Posted

July 18, 2003

Study Start

September 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations

US(10)