- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00039104
Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer
A Phase II, Open-Label, Randomized Trial of Zoledronic Acid (Zometa™) and BMS-275291 (NSC#713763) in Patients With Hormone Refractory Prostate Cancer
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. To evaluate the confirmed response rate of hormone refractory prostate cancer patients treated with Zometa with BMS-275291.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity profile associated with this treatment in this patient population.
II. To evaluate the overall and progression-free survival associated with this treatment regimen.
III. To explore changes markers for bone turnover, fPYR, fDPYR, and serum samples for cross-linked N-telopeptides from baseline.
IV. To assess changes in bone tumor metabolism after treatment using PET scans. V. To assess changes in MMP-1, MMP-9, VEGF and bFGF from baseline after treatment.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and participating center.
ARM I: Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.
ARM II (CLOSED TO ACCRUAL AS OF 10/10/2003): Patients receive zoledronate as in Arm I.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Minnesota
-
Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Histologically or cytologically confirmed (adeno)carcinoma of the prostate refractory to hormone therapy
Metastatic bone disease, as documented by bone scan and confirmed by x-rays, CT scan or MRI scan
- Note: Patients may also have measurable disease in the lymph nodes (retroperitoneal, pelvic or inguinal only), prostate and /or prostatic bed; measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm =< 21 days prior to registration
- PSA progression defined as two consecutive increases in PSA value over the previous reference value; the first increase of PSA should occur no earlier than one (1) week after the reference measurement; all patients need to demonstrate continued PSA elevation with an increasing PSA four weeks after the required cessation of their antiandrogen treatment; the required cessation period is 4 weeks for flutamide, nilutamide, and Megace-based treatment, and 8 weeks for bicalutamide-based treatment
One of the following:
- Continuing primary androgen suppression (LHRH agonist)
- Orchiectomy
- WBC >= 2000/mm^3
- Absolute neutrophil count (ANC) >= 1500/mm^3
- PLT >= 100,000/mm^3
- Hgb >= 9.0 g/dL
- Total bilirubin =< institutional upper normal limits (UNL)
- AST =< 1.5 x UNL
- Serum creatinine =< 1.5 x UNL
- PSA >= 5 ng/mL
- Serum testosterone < 50 ng/dL =< 3 months prior to registration
- Estimated life expectancy of >= 6 months
- ECOG Performance Status (PS) 0, 1, or 2
- Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
- If sexually active, willing to use an accepted and effective method of contraception consistently for the duration of study participation
Exclusion Criteria:
Any of the following:
- > 2 prior chemotherapy regimen
- > 2 non-hormonal treatments for metastatic disease (including biologics, gene therapy, angiogenesis inhibitors, etc., but excluding external radiotherapy)
- Prior therapy with a matrix metalloproteinase inhibitor (MMPI)
- Immunotherapy =< 4 weeks prior to study entry
- Biologic therapy =< 4 weeks prior to study entry
- Radiation therapy =< 4 weeks prior to study entry
- Concomitant hormonal treatment (except LHRH)
- Prior use of systemic radiopharmaceuticals such as samarium and strontium
- PC-Spes =< 4 weeks prior to study entry
- Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
- Other concurrent chemotherapy, immunotherapy, or radiotherapy directed at the cancer
- Other therapy or supportive care that is considered investigational
- Known CNS metastases
- Known visceral metastases (pulmonary, liver, kidney, splenic lesions); patients with retroperitoneal, pelvic or inguinal lymph node metastases and/or disease in the prostate (or prostatic bed) will not be excluded
Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris, cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients receiving combination anti-retroviral therapy
- Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease free for >= 5 years
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Arm I (rebimastat, zoledronic acid)
Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.
|
Korrelative Studien
Gegeben IV
Andere Namen:
Given PO
Andere Namen:
|
Experimental: Arm II (zoledronic acid)
Patients receive zoledronate as in Arm I.
|
Korrelative Studien
Gegeben IV
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Confirmed response (PSA decline of greater than 50% confirmed at least four weeks apart)
Zeitfenster: Up to 2 years
|
Up to 2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall survival time
Zeitfenster: From registration to death due to any cause, assessed for up to 2 years
|
The distribution of survival time will be estimated using the method of Kaplan-Meier.
|
From registration to death due to any cause, assessed for up to 2 years
|
Time to disease progression
Zeitfenster: From registration to documentation of disease progression, assessed up to 2 years
|
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
|
From registration to documentation of disease progression, assessed up to 2 years
|
Duration of PSA response or duration of PSA control
Zeitfenster: Up to 2 years
|
The distribution of this response duration will be estimated using the method of Kaplan-Meier.
|
Up to 2 years
|
Incidence of toxicity as per NCI CTCAE version 2.0
Zeitfenster: Up to 2 years
|
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
|
Up to 2 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Roberto Pili, Mayo Clinic
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCI-2012-02799
- MC0151
- N01CM17104 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Labor-Biomarker-Analyse
-
Vanderbilt University Medical Center4DMedicalAbgeschlossen
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Noch keine RekrutierungHIV-Infektionen | Hepatitis B
-
Duke UniversityZurückgezogenAntikoagulations- und Thrombose-Point-of-Care-Test (AT-POCT)Vereinigte Staaten
-
Columbia UniversityAbgeschlossen
-
McGill University Health Centre/Research Institute...Northwestern UniversityRekrutierungApnoe der FrühgeburtlichkeitKanada
-
Emory UniversityDermatology FoundationBeendetKutaner Lupus erythematodesVereinigte Staaten