NCT00736814

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is comparing different combination chemotherapy regimens to see how well they work as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
117

participants targeted

Target at P75+ for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
Last Updated

February 24, 2011

Status Verified

August 1, 2009

First QC Date

August 15, 2008

Last Update Submit

February 23, 2011

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate (complete and partial responses)

Secondary Outcomes (5)

  • Disease control rate

  • Response duration

  • Progression-free survival

  • Overall survival

  • Toxicity

Study Arms (5)

Arm I

ACTIVE COMPARATOR

Patients receive standard chemotherapy of docetaxel and carboplatin.

Drug: carboplatinDrug: docetaxel

Arm II, Genotype A1

EXPERIMENTAL

Patients receive docetaxel and vinorelbine ditartrate.

Drug: docetaxelDrug: vinorelbine tartrate

Arm II, Genotype A2

EXPERIMENTAL

Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.

Drug: gemcitabine hydrochlorideDrug: vinorelbine tartrate

Arm II, Genotype B1

EXPERIMENTAL

Patients receive docetaxel and carboplatin.

Drug: carboplatinDrug: docetaxel

Arm II, Genotype B2

EXPERIMENTAL

Patients receive gemcitabine hydrochloride and carboplatin.

Drug: carboplatinDrug: gemcitabine hydrochloride

Interventions

carboplatinDRUG

Given intravenously

Arm IArm II, Genotype B1Arm II, Genotype B2
docetaxelDRUG

Given intravenously

Arm IArm II, Genotype A1Arm II, Genotype B1
gemcitabine hydrochlorideDRUG

Given intravenously

Arm II, Genotype A2Arm II, Genotype B2
vinorelbine tartrateDRUG

Given intravenously

Arm II, Genotype A1Arm II, Genotype A2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven or radiologically and clinically suspected stage IIIB (with malignant pleural effusion) or IV non-small cell lung cancer * Unresectable disease * At least 1 measurable lesion (\> 10 mm with spiral CT scan or \> 20 mm with conventional CT scan) * No symptomatic or untreated brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 12 weeks * ANC ≥ 1,500/mm³ * Hemoglobin \> 9.0 g/dL * Platelet count ≥ 100,000/mm³ * AST and ALT \< 2 times upper limit of normal (ULN) * Bilirubin \< 1.5 mg/dL * Creatinine \< 1.5 times ULN * Not pregnant or nursing * No serious uncontrolled systemic intercurrent illness, including any of the following: * Acute myocardial infarction * Uncontrolled arrhythmia * Uncontrolled heart failure * Sepsis * Poorly controlled diabetes * No other malignancy within the last 5 years, except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior radiotherapy, including cranial irradiation * At least 3 weeks since prior major surgery * No prior systemic chemotherapy except adjuvant chemotherapy provided it was completed more than 12 months ago

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinDocetaxelGemcitabineVinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Byung Chul Cho

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

June 1, 2008

Last Updated

February 24, 2011

Record last verified: 2009-08

Locations

KR(1)