NCT00430651

Brief Summary

This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at below P25 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

10 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

July 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

3.8 years

First QC Date

February 1, 2007

Last Update Submit

January 27, 2009

Conditions

Non-Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer2nd line chemotherapyDocetaxel

Outcome Measures

Primary Outcomes (1)

  • Comparison of the overall survival between the two treatment groups

    1 year

Secondary Outcomes (3)

  • Comparison of the objective response rates between the two treatment groups

    Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

  • Evaluation and comparison of the toxicity between the two treatment groups

    Toxicity assessment on each chemotherapy cycle

  • Measurement and comparison of the health-related quality of life of patients on both treatment groups

    Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

Docetaxel + Carboplatin

Drug: DocetaxelDrug: Carboplatin

2

EXPERIMENTAL

Docetaxel

Drug: Docetaxel

Interventions

DocetaxelDRUG

Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles

Also known as: Taxotere
12
CarboplatinDRUG

Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed NSCLC.
  • ECOG Performance Status 0-2.
  • No previous treatment with Docetaxel.
  • Measurable Disease.
  • Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.
  • Adequate liver kidney and bone marrow function.
  • Patients must be able to understand the nature of this study and give written informed consent.

You may not qualify if:

  • Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Women who are pregnant or lactating.
  • Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.
  • Serious neurologic or psychiatric disease.
  • Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.
  • Active uncontrolled infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athnes, Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases

Athens, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Pireaus

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DocetaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Vassilis Georgoulias, MD

    University Hospital of Crete, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

July 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations

GR(10)