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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center Identifier:
First received: October 28, 2005
Last updated: January 20, 2016
Last verified: January 2016

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 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Proportion of patients with early hormone refractory prostate cancer experiencing decrease in measurable disease after treatment with lapatinib (GW572016). [ Time Frame: Every 12 weeks until disease progression ]
    Radiographic response will be measured using RECIST criteria for patients with measurable disease every 12 weeks. Subjects will be evaluated for CR (complete response), PR (partial response), SD (stable disease) or PD (progressive disease)

Secondary Outcome Measures:
  • Number of patients experiencing adverse events [ Time Frame: every 4 weeks of treatment ]
    Adverse events will be assessed (graded) using CTCAE critera

  • Time to PSA progression [ Time Frame: every 4 weeks of treatment ]
    Efficacy monitoring will be assessed by serum PSA for those subjects without radiographic, measurable disease. Decrease in PSA value from baseline by > 50 % for 2 successive evaluations at least 4 weeks apart will be considered PSA repsonse.

  • Predictive molecular markers in response to treatment with lapatinib (GW572016) [ Time Frame: every 4 weeks of treatment ]
    To assess the correlation between expression of molecular markers and patient response to treatment with GW572016

Enrollment: 35
Study Start Date: October 2005
Study Completion Date: May 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Trial
Single Arm Trial
Drug: lapatinib ditosylate
1500 mg, daily until disease progression
Other Name: GW572016

Detailed Description:



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


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


  • 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


  • 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)


  • 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
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Please refer to this study by its identifier: NCT00246753

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
National Cancer Institute (NCI)
Principal Investigator: Young Whang, MD, PhD UNC Lineberger Comprehensive Cancer Center
  More Information

Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00246753     History of Changes
Other Study ID Numbers: LCCC 0505
CDR0000550151 ( Other Identifier: PDQ number )
Study First Received: October 28, 2005
Last Updated: January 20, 2016

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:
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 processed this record on June 27, 2017