- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00074139
Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them at different times, may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the pharmacokinetic profile of docetaxel, doxorubicin, and cyclophosphamide in women with advanced breast cancer.
Secondary
- Compare the pharmacokinetic profile of this regimen in these patients vs the historical pharmacokinetic profile of docetaxel.
OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 followed by doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 22.
- Arm II: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 1 followed by doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 22.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients may receive additional therapy at the discretion of the treating physician.
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study within 7 months.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106-5055
- Ireland Cancer Center
-
-
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 advanced breast cancer
- Adjuvant setting for high-risk disease allowed
- No symptomatic evidence or history of brain metastases
- No leptomeningeal metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 to 69
Sex
- Female
Menopausal status
- Not specified
Performance status
- WHO 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count at least 2,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic
- Bilirubin less than upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN)
- Alkaline phosphatase no greater than 5 times ULN
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- LVEF or shortening fraction greater than lower limit of normal by MUGA or echocardiography
- Cardiac function normal
- No congestive heart failure
- No unstable angina pectoris
- No myocardial infarction within the past year
- No uncontrolled hypertension
- No high-risk uncontrolled arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No active uncontrolled infection
- No active peptic ulcer
- No unstable diabetes mellitus
- No other serious illness or medical condition
- No contraindication to corticosteroids
- No pre-existing grade 2 or greater motor or sensory neurotoxicity
- No psychological, social, familial, or geographical reason that would preclude study follow-up
- No history of significant neurologic or psychiatric disorder (e.g., psychotic disorder, dementia, or seizures) that would preclude understanding and giving informed consent
- No other neoplasm within the past 10 years except curatively treated nonmelanoma skin cancer, carcinoma in situ of the cervix, ipsilateral ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 6 months since prior anthracycline or taxoid (e.g., paclitaxel or docetaxel) therapy
- No prior cumulative anthracycline dose greater than 240 mg/m^2
Endocrine therapy
- Concurrent corticosteroid treatment allowed provided treatment was initiated more than 6 months before study entry and at a dose of less than 20 mg of methylprednisolone or equivalent
- No concurrent ovarian hormonal replacement therapy
Radiotherapy
- Not specified
Surgery
- More than 2 weeks since prior major surgery
Other
- More than 30 days since prior participation in another clinical trial with any investigational drug or device
- No other concurrent experimental drugs
- No other concurrent systemic anticancer therapy
- No concurrent aminoglycoside antibiotics
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Beth A. Overmoyer, MD, FACP, Case Comprehensive Cancer Center
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
Nøgleord
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Docetaxel
- Cyclofosfamid
- Doxorubicin
- Liposomal doxorubicin
Andre undersøgelses-id-numre
- CWRU040314
- CDR0000343609 (Registry Identifier: PDQ (Physician Data Query))
- CWRU-AVEN-1103
- AVENTIS-XRP6976D/1001
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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