Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00065117

Enrollment

180

Registered

2003-07-18

Start date

2003-09-30

Completion date

2004-02-29

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms, Metastases, Neoplasm

Keywords

metastatic, colorectal, first-line, adjuvant, cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

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.

Interventions

DRUGZD6126

DRUGPlacebo

DRUG5-fluorouracil

DRUGleucovorin

DRUGoxaliplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026