- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00005963
Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer
Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic Breast 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 chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have metastatic breast cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in women with metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to progression, and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients. IV. Assess the common functional polymorphisms in genes involved in chemotherapeutic response to improve prediction of clinical outcomes and provide insight into the potential for genotype-specific drug dosage.
OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), partial response (PR), or complete response (CR) may receive 4 additional courses past SD, PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Arizona
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Scottsdale, Arizona, Forente stater, 85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Peoria, Illinois, Forente stater, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Forente stater, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Forente stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Forente stater, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Forente stater, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Forente stater, 67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans, Louisiana, Forente stater, 70121
- CCOP - Ochsner
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Michigan
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Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Clinic
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Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Forente stater, 68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Forente stater, 58501
- Medcenter One Health System
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Fargo, North Dakota, Forente stater, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, Forente stater, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, Forente stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City, South Dakota, Forente stater, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forente stater, 57104
- CCOP - Sioux Community Cancer Consortium
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the breast Measurable disease At least 20 mm in at least 1 dimension Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than ULN OR SGOT/SGPT no greater than ULN Alkaline phosphatase no greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Other: No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No active unresolved infection No prior hypersensitivity reaction to docetaxel No grade 2 or greater sensory or motor neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF) during the first course of study therapy Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed More than 1 year since prior paclitaxel, docetaxel, cisplatin, or carboplatin No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to breast, chest wall, or axilla No prior radiotherapy to greater than 30% of bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered Other: More than 7 days since prior IV antibiotics No concurrent experimental drugs
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: docetaxel + carboplatin
This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1.
Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients who achieve stable disease (SD), partial response (PR), or complete response (CR) may receive 4 additional courses past SD, PR, or CR.
Patients are followed every 6 months for 2 years and then annually for 3 years.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
objektiv svarprosent
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
tid til progresjon
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
overlevelse
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCCTG-N9932
- CDR0000067945 (Registeridentifikator: PDQ (Physician Data Query))
- NCI-2012-02341 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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