NCT00004887

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel and carboplatin is more effective than standard chemotherapy for advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.

Trial Health

55
Monitor

Trial Health Score

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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

July 24, 2003

Completed
Last Updated

September 20, 2013

Status Verified

March 1, 2000

First QC Date

March 7, 2000

Last Update Submit

September 19, 2013

Conditions

Lung Cancer

Keywords

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

Interventions

carboplatinDRUG
cisplatinDRUG
ifosfamideDRUG
mitomycin CDRUG
paclitaxelDRUG
vinblastine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed inoperable advanced non-small cell lung cancer * Stage IIIA, IIIB, or IV * Not eligible for curative radiotherapy or surgery * Measurable or evaluable disease * No bony lesions as only site of measurable disease * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 (ECOG 3 allowed in some cases) Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases) Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Other: * Not pregnant * Fertile patients must use effective contraception during and for 3 months after study * No active infection * No other serious systemic disorder that would preclude compliance * No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer * No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * Prior radiotherapy allowed if measurable disease outside of irradiated field Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinCisplatinIfosfamideMitomycinPaclitaxelVinblastine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMitomycinsIndolequinonesQuinonesAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolizidinesIndolizines

Study Officials

  • Nick Thatcher, PhD, FRCP

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

July 24, 2003

Study Start

January 1, 1999

Last Updated

September 20, 2013

Record last verified: 2000-03

Locations

GB(1)