- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00348816
Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy.
Secondary
- Determine the tolerability of this regimen in these patients.
- Determine the progression-free survival, based on PSA progression, of these patients.
- Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy.
- Determine if the velocity of subsequent PSA failure impacts survival of these patients.
Tertiary
- Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy.
Quaternary: To collect data on a contemporary cohort to those on study that received radiation alone. We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes.
OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Texas
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San Antonio, Texas, Forenede Stater, 78229-3900
- University of Texas Health Science Center at San Antonio
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically confirmed prostate cancer
- Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago
- No lymph node-positive prostate cancer
No documented metastatic disease
- CT scan of the abdomen and pelvis negative (within the past 6 months)
- No bone pain OR negative bone scan (within the past 6 months)
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin normal
- ALT and AST ≤ 1.5 times upper limit of normal
- Alkaline phosphatase normal
- Fertile patients must use effective contraception
- No peripheral neuropathy > grade 1
- No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer
- No serious illness with a life expectancy of < 5 years
- No concurrent medical, psychological, or social circumstance that would preclude study compliance
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Exclusion Criteria:
- No prior orchiectomy
- No prior chemotherapy regimen for this disease
- No prior pelvic radiotherapy
No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride
- Preoperative androgen manipulation for a duration of ≤ 3 months allowed
- No prior immunotherapy
- No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
No concurrent herbal or alternative regimens including, but not limited to, any of the following:
- Saw palmetto
- PC-SPES
- Shark cartilage
- No other concurrent investigational agents
- No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
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 |
---|---|
Eksperimentel: Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles).
Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel
|
Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles).
Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Andre navne:
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles).
Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Andre navne:
Radical prostatectomy as part of standard care
Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue.
The initial dose will be 4500 cGy.
With the final boost, the total dose will be 6840-6900 cGy.
(4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
Tidsramme: 5 years
|
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
|
5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Samlet overlevelse
Tidsramme: 5 år
|
5 år
|
|
Progression-free Survival Based on PSA Progression
Tidsramme: 5 years
|
Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.
|
5 years
|
Correlation Between Velocity of Subsequent PSA Failure and Survival
Tidsramme: 5 years
|
5 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Gregory P. Swanson, MD, The University of Texas Health Science Center at San Antonio
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Genitale neoplasmer, mandlige
- Prostatasygdomme
- Prostatiske neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Docetaxel
- Prednison
Andre undersøgelses-id-numre
- CDR0000486733
- HSC20050377H. (Anden identifikator: UTHSCSA IRB)
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