NCT00003696

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P25-P50 for phase_3 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

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 17, 2013

Status Verified

November 1, 2001

First QC Date

November 1, 1999

Last Update Submit

September 16, 2013

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (4)

  • Overall survival

  • Response rate

  • Duration of response

  • Toxicity

Interventions

carboplatinDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
etoposideDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically proven extensive stage small cell lung cancer, not previously treated with chemotherapy or radiotherapy except for symptomatic brain metastases * Measurable or evaluable disease * Ascites, pleural effusions, osteolytic and osteoblastic bone metastases are not measurable or evaluable PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (unless due to liver metastases) Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No cardiac failure or rhythm disturbances requiring medication Other: * No history of hypersensitivity to castor oil * No active uncontrolled infection * No nonmalignant disease presenting a poor medical risk * Not pregnant * Fertile patients must use effective contraception during and for 3 months after the study PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * Palliative radiotherapy allowed (indicator lesion should be outside of irradiated field) Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

CarboplatinCyclophosphamideDoxorubicinEtoposidePaclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Egbert F. Smit, MD

    Free University Medical Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1998

Last Updated

September 17, 2013

Record last verified: 2001-11

Locations

NL(1)