NCT00006374

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 more effective for treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combining topotecan and paclitaxel with that of combining etoposide and cisplatin in treating patients who have extensive-stage small cell lung cancer.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 1999

Shorter than P25 for phase_2 lung-cancer

Status
withdrawn

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, 1999

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

June 9, 2004

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

1.7 years

First QC Date

October 4, 2000

Last Update Submit

January 14, 2014

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancerrecurrent small cell lung cancer

Interventions

filgrastimBIOLOGICAL
cisplatinDRUG
etoposideDRUG
paclitaxelDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of extensive stage small cell lung cancer At least 1 bidimensionally measurable non CNS lesion At least 1 cm in one diameter and at least 2 cm in another diameter by CT or MRI scan At least 2 cm in two diameters by x-ray, ultrasound, or for palpable tumor masses by physical exam Measurable skin lesion at least 1 cm in at least one diameter by photography No symptomatic CNS and/or leptomeningeal metastases requiring corticosteroid therapy to control symptoms PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Hemoglobin at least 9.0 g/dL Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT, SGPT, and alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No preexisting cardiac disease No congestive heart failure No cardiac arrhythmia requiring therapy No myocardial infarction within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months before, during, and for at least 4 weeks after study No active uncontrolled infection No other concurrent or prior malignancies within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical problem or any other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 24 hours since prior radiotherapy if no marked bone marrow suppression expected At least 6 weeks since prior radiotherapy to measurable lesion if evidence of progression Concurrent radiotherapy for bone pain control allowed Surgery: At least 3 weeks since prior surgery Other: At least 30 days or 5 half lives (whichever is longer) since prior investigational drug No other concurrent investigational drugs

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

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

FilgrastimCisplatinEtoposidePaclitaxelTopotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Nathan Levitan, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

June 9, 2004

Study Start

October 1, 1999

Primary Completion

June 1, 2001

Study Completion

June 1, 2001

Last Updated

January 15, 2014

Record last verified: 2014-01