- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003900
Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
A Phase II Study of Irinotecan (CPT-11) and Docetaxel (Taxotere) in Patients With Recurrent Non-Small Cell Lung Cancer
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.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-small cell lung cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES: I. Evaluate the response rate of previously treated patients with recurrent non-small cell lung cancer after treatment with irinotecan and docetaxel. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival in this patient population.
OUTLINE: Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Saskatchewan
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Regina, Saskatchewan, Canada, S4S 6X3
- Saskatchewan Cancer Agency
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Peoria, Illinois, Forenede Stater, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Forenede Stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Forenede Stater, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Forenede Stater, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Quain & Ramstad Clinic, P.C.
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Fargo, North Dakota, Forenede Stater, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, Forenede Stater, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forenede Stater, 57105-1080
- CCOP - Sioux Community Cancer Consortium
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Reconfirmation of NSCLC required only if complete response for greater than 1 year Measurable or evaluable disease Tumor shrinkage or stability for at least 4 weeks on initial chemotherapy CNS metastases allowed, if symptoms controlled for greater than 8 weeks after surgery or radiotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection At least 5 years since any other prior malignancy except curatively treated basal or squamous cell skin cancer, carcinoma in situ, or other cancers No grade 2 or worse peripheral neuropathy No uncontrolled diabetes mellitus No other serious underlying disease Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose cisplatin as a radiosensitizer No prior irinotecan or docetaxel At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other anticonvulsants
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: irinotecan + docetaxel
Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1.
Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years or until death.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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svarprocent
Tidsramme: Op til 5 år
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Op til 5 år
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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samlet overlevelse
Tidsramme: Op til 5 år
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Op til 5 år
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Docetaxel
- Irinotecan
Andre undersøgelses-id-numre
- NCCTG-982453
- CDR0000067071 (Registry Identifier: PDQ (Physician Data Query))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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