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Lapatinib in Treating Patients With Recurrent Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103194
  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 recurrent prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: lapatinib ditosylate
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: Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident By a Rising PSA

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

Primary Outcome Measures:
  • Percentage of PSA response rate defined as a 50% or greater decline in the serum PSA level [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the percentage of patients with hormone-sensitive recurrent prostate cancer treated with lapatinib who experience > 50% decline in serum prostate-specific antigen (PSA).

Secondary

  • Determine the duration of PSA decline in patients treated with this drug.
  • Determine the change in slope of a linear graph depicting PSA values in these patients before, during, and after treatment with this drug.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine the time to progression and 2-year progression-free survival of patients treated with this drug.
  • Correlate epidermal growth factor receptor expression/signaling with change in PSA in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Biochemical disease progression after prior definitive surgery or radiotherapy, as evidenced by all of the following:

    • Three consecutive rising prostate-specific antigen (PSA) levels obtained ≥ 6 weeks apart within the past 6 months
    • Most recent PSA > 0.4 ng/mL after prostatectomy (1.5 ng/mL after radiotherapy)
    • PSA doubling time < 1 year
  • Hormone-sensitive disease, as evidenced by total testosterone > 150 ng/dL within the past 4 weeks
  • No evidence of metastatic disease by physical exam, CT scan, MRI, or bone scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • Alkaline phosphatase normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • PT/INR normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • Cardiac ejection fraction normal by echocardiogram or MUGA within the past 4 weeks
  • No unstable arrhythmias on ECG

    • Rate-controlled asymptomatic atrial fibrillation allowed
  • No symptomatic congestive heart failure
  • No unstable angina pectoris

Gastrointestinal

  • Able to swallow and retain oral medication
  • No GI tract disease resulting in either of the following:

    • Malabsorption syndrome
    • Requirement for IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

Other

  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib
  • No other uncontrolled illness
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior vaccine therapy for prostate cancer
  • No prior immunotherapy for prostate cancer

Chemotherapy

  • At least 1 year since prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

  • At least 1 year since prior neoadjuvant or adjuvant hormonal therapy
  • At least 1 year since prior therapy that modulates testosterone levels (e.g., luteinizing hormone-releasing hormone agonists/antagonists or antiandrogens)
  • More than 6 months since prior 5α-reductase inhibitors
  • More than 6 months since prior megestrol
  • More than 6 months since prior systemic steroids
  • More than 6 months since prior and no concurrent ketoconazole

Radiotherapy

  • See Disease Characteristics
  • Prior radiotherapy as curative salvage therapy allowed

Surgery

  • See Disease Characteristics
  • Prior surgery as curative salvage therapy allowed
  • No prior surgery affecting gastrointestinal (GI) tract absorption

Other

  • Prior local ablative procedures as curative salvage therapy allowed
  • At least 1 year since prior investigational agents
  • No concurrent CYP3A4 inducers or inhibitors

    • At least 7 days to 6 months since prior CYP3A4 inducers or inhibitors as determined by the treating physician
  • More than 6 months since prior herbal supplements
  • No concurrent antacids within 1 hour before or after study drug administration
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103194

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Glenn Liu, MD University of Wisconsin, Madison
Investigator: Jason R. Gee, MD University of Wisconsin, Madison
  More Information

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

Publications of Results:
Liu G, Chen Y, Pins M, et al.: E5803: A phase II trial of lapatinib (GW572016) in patients with recurrent prostate cancer as evident by a rising PSA. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-169, 2008.

Study ID Numbers: CDR0000409729, ECOG-E5803
Study First Received: February 7, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00103194  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Lapatinib
Urogenital Neoplasms
Genital Diseases, Male
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 15, 2009