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Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00246753
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: lapatinib ditosylate
Procedure: laboratory biomarker analysis
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Lapatinib Lapatinib Ditosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA response [ Designated as safety issue: No ]
  • PSA progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Duration of stable disease [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the proportion of patients with hormone-refractory prostate cancer who experience > 50% decline in 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Hormone-refractory disease

    • Prior androgen-deprivation therapy (either bilateral orchiectomy or medical castration resulting in a testosterone level < 50 ng/dL) for prostate cancer required

      • Biochemical progression on androgen-deprivation therapy with rising PSA, defined as elevated PSA (≥ 5 ng/mL) that has risen serially from baseline on 2 occasions ≥ 1 week apart
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Cardiac ejection fraction normal by ECHO or MUGA
  • Fertile patients must use effective contraception
  • Able to swallow and retain oral medication
  • No history of allergic reaction to compounds of similar chemical or biological composition to lapatinib ditosylate
  • No other concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • No psychiatric illness or social situation that would limit study compliance
  • No HIV positivity
  • No gastrointestinal (GI) tract disease resulting in an inability to take oral medication
  • No malabsorption syndrome
  • No requirement for IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
  • No current active hepatic or biliary disease (with the exception of patients with Gilbert syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapies
  • No prior chemotherapy for prostate cancer
  • No prior or concurrent cytotoxic chemotherapy
  • At least 4 weeks since prior anti-androgen therapy, including flutamide (6 weeks for bicalutamide and nilutamide)
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior surgery
  • At least 4 weeks since other prior hormonal therapy, including ketoconazole, megestrol acetate, and aminoglutethimide
  • At least 4 weeks since other prior chemotherapy
  • At least 4 weeks since prior investigational agents
  • At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:

    • Antibiotics (clarithromycin, erythromycin, troleandomycin)
    • Antifungals (itraconazole, ketoconazole, fluconazole [> 150 mg daily], voriconazole)
    • Antiretrovirals or protease inhibitors (delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir)
    • Calcium channel blockers (verapamil, diltiazem)
    • Antidepressants (nefazodone, fluvoxamine)
    • Gastrointestinal agents (cimetidine, aprepitant)
    • Grapefruit or grapefruit juice
  • At least 6 months since prior and no concurrent amiodarone
  • At least 14 days since prior and no concurrent herbal or dietary supplements
  • At least 14 days since prior and no concurrent inducers of CYP3A4, including any of the following:

    • Antibiotics (all rifamycin class agents [e.g., rifampicin, rifabutin, rifapentine])
    • Anticonvulsants (phenytoin, carbamazepine, barbiturates [e.g., phenobarbital])
    • Antiretrovirals (efavirenz, nevirapine)
    • Glucocorticoids (cortisone [> 50 mg], hydrocortisone [> 40 mg], prednisone [> 10 mg], methylprednisolone [> 8 mg], dexamethasone [> 1.5 mg])

      • Daily oral glucocorticoid doses ≤ 1.5 mg of dexamethasone (or equivalent) allowed
    • Hypericum perforatum (St. John's wort)
    • Modafinil
  • No prior ErbB family-targeting therapies
  • No prior surgical procedures affecting absorption
  • No concurrent local radiotherapy for pain control or life-threatening situations (i.e., spinal cord compression, superior vena cava syndrome)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246753

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Young Whang, MD, PhD UNC Lineberger Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000550151, UNC-LCCC-0505
Study First Received: October 28, 2005
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00246753  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Lapatinib
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009