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Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC

NCT00499109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2014-07-09

Study results available
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Summary

This is a clinical research study to evaluate if chemotherapy in the experimental arm (E) results in a better outcome compared to patients in the standard of care arm (C).

2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level. In arm C, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin, i.e., standard of care.

Conditions

Interventions

DRUG

Docetaxel

GD Group: 40 mg/m\^2 on days 1 and 8, every 21 days DCb Group: 75 mg/m\^2 on day 1 DV Group: 50 mg/m\^2 on days 1 and 15, every 28 days

DRUG

Vinorelbine

DV Group: 35 mg/m\^2 on days 1 and 15

DRUG

Carboplatin

GCb Group: Area under the curve (AUC) 5 on day 1, every 21 days DCb Group: AUC 6 on day 1, every 21 days Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed.

DRUG

Gemcitabine

GCb Group: 1,250 mg/m\^2 on days 1 and 8 GD Group: 1,250 mg/m\^2 on days 1 and 8 Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Charles Williams, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2013-04-30
Completion
2013-11-30

Countries

  • United States
  • Germany
  • Puerto Rico

Study Locations

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Entities

Drugs
Diseases
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 NCT00499109 on ClinicalTrials.gov