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Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NRR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00246753
Recruitment Status : Completed
First Posted : October 30, 2005
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: lapatinib ditosylate Phase 2

Detailed Description:



  • Determine the proportion of patients with hormone-refractory prostate cancer who experience > 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer
Study Start Date : October 2005
Actual Primary Completion Date : July 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: lapatinib ditosylate
1500 mg, daily until disease progression
Other Name: GW572016

Primary Outcome Measures :
  1. Number of Patients Experiencing Decline in Prostate-specific Antigen [ Time Frame: 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.

Secondary Outcome Measures :
  1. Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: 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.

  2. Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016) [ Time Frame: 4 years ]
    To assess the correlation between expression of molecular markers and patient response to treatment with GW572016

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00246753

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

Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00246753    
Other Study ID Numbers: LCCC 0505
CDR0000550151 ( Other Identifier: PDQ number )
First Posted: October 30, 2005    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: May 2017
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action