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Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NRR)
A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- Determine the proportion of patients with hormone-refractory prostate cancer who experience > 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate.
Secondary
- Determine the safety of this drug in these patients.
- Determine the time to PSA progression in patients treated with this drug.
- Determine the molecular correlates and predictive biomarkers of response in patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Serum samples are collected for biomarker analysis at baseline and every 4 weeks.
After completion of study treatment, patients are followed at 4 weeks.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Durham, North Carolina, Verenigde Staten, 27710
- Duke Comprehensive Cancer Center
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Raleigh, North Carolina, Verenigde Staten, 27607
- Rex Cancer Center at Rex Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
- On androgen deprivation therapy for prostate cancer (either bilateral orchiectomy or medical castration with the testosterone level of <50 ng/dl)
- Biochemical progression on androgen deprivation therapy with minimum PSA of 5 ng/ml. Progression is defined as two successive rises in PSA, measured at least one week apart. See section 4.1 for additional criteria.
- Minimum of 4-6 weeks off anti-androgen therapy (4 weeks for flutamide, 6 weeks for bicalutamide and nilutamide).
- Minimum of 4 weeks off other hormonal therapy (i.e. ketoconazole, megestrol acetate, aminoglutethimide)
- Minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other investigational agent.
- Patients must discontinue use of any herbal supplements prior to study initiation.
- No prior or concurrent exposure to cytotoxic chemotherapy.
- Age > 18 years.
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or multigated acquisition scan (MUGA) scan.
- Men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation since the effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown.
- Ability to swallow and retain oral medication.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients who have had prior treatment with ErbB family targeting therapies.
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Prior chemotherapy for prostate cancer
- Patients with known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- A history of a positive HIV test in the past.
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors (please refer to section 3.2.2 for a list of medications).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Single Arm Trial
Single Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity.
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1500 mg, daily until disease progression
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Patients Experiencing Decline in Prostate-specific Antigen
Tijdsspanne: 4 years
|
Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.
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4 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Time to Prostate-Specific Antigen (PSA) Progression
Tijdsspanne: 4 years
|
Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.
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4 years
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Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)
Tijdsspanne: 4 years
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To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
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4 years
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Young Whang, MD, PhD, UNC Lineberger Comprehensive Cancer Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LCCC 0505
- CDR0000550151 (Andere identificatie: PDQ number)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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