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Colorectal Cancer RECHALLENGE

NCT00988897 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2009-12-23

No results posted yet for this study

Summary

Primary Objective:

* To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy.

Secondary Objective:

* To evaluate other measures of tumour's responses and safety.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

OXALIPLATIN (SR96669)

Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV

DRUG

5-FLUOROURACIL (5-FU)

Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV

DRUG

LEUCOVORIN (LV)

Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV

DRUG

BEVACIZUMAB

Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV

Sponsors & Collaborators

Principal Investigators

  • Medical Affairs · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988897 on ClinicalTrials.gov