- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00416533
Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride, and prednisone in patients with hormone-refractory advanced prostate cancer.
Secondary
- Assess if treatment with docetaxel, doxorubicin hydrochloride, and prednisone will improve health-related quality of life of these patients.
- Assess the toxicity of docetaxel, doxorubicin hydrochloride, and prednisone.
- Assess response rate in measurable disease.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, after completion of 3 courses, and at disease progression.
After completing study treatment, patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with any of the following:
- Prostate-specific antigen ≥ 10 mg/dL
- Bone disease
- Bidimensional soft tissue disease
- Evaluable disease
- Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal
- Disease not amenable to local curative treatment
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine < 2.0 mg/dL
- SGPT and SGOT < 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ ULN
- Hemoglobin ≥ 10 g/dL
- Ejection fraction ≥ 50%
- Peripheral neuropathy ≤ grade 1
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No previous history of or concurrent malignancy, except for any of the following:
- Inactive nonmelanoma skin cancer
- Disease-free for five or more years
- Adequately treated stage I or II cancer from which patient is currently in complete remission
- No other serious medical illness that would limit survival to less than 3 months
- No psychiatric condition that would prevent informed consent
- No active, uncontrolled bacterial, viral, or fungal infection
- No hemorrhagic disorder
- No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No new hormonal treatment within the past 4 weeks
- No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
- Prior bisphosphonates allowed
- At least 2 weeks since prior radiotherapy
- No other concurrent chemotherapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Frank M. Torti, MD, MPH, Wake Forest University Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (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
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Genitale neoplasmer, hanner
- Prostata sykdommer
- Prostatiske neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Docetaxel
- Prednison
- Doxorubicin
- Liposomal doksorubicin
Andre studie-ID-numre
- CCCWFU-85302
- CDR0000466318 (Registeridentifikator: PDQ (Physician Data Query))
- CCCWFU-BG04-264
- AVENTIS-CCCWFU-85302
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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