GW572016 (Lapatinib) in Treating Patients With Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00103194
First received: February 7, 2005
Last updated: April 12, 2012
Last verified: April 2012

February 7, 2005
April 12, 2012
September 2005
July 2009   (final data collection date for primary outcome measure)
Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years ] [ Designated as safety issue: No ]

PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.

CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.

PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later.

Not Provided
Complete list of historical versions of study NCT00103194 on ClinicalTrials.gov Archive Site
  • The Change in PSA Slope With GW572016 (Lapatinib) [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years ] [ Designated as safety issue: No ]
    PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.
  • Progression-free Survival Rate at 2 Years [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years ] [ Designated as safety issue: No ]
    Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.
  • Relationship Between Progression-free Survival and EGFR Expression Levels [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years ] [ Designated as safety issue: No ]
    The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.
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GW572016 (Lapatinib) in Treating Patients With Recurrent Prostate Cancer
Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident By a Rising PSA

RATIONALE: GW572016 (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 GW572016 (lapatinib) works in treating patients with recurrent prostate cancer.

OBJECTIVES:

Primary

  • Determine the percentage of patients with hormone-sensitive recurrent prostate cancer treated with GW572016 (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 GW572016 (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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: GW572016 (lapatinib)
GW572016 (lapatinib) was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities.
Other Names:
  • GW572016
  • lapatinib
Experimental: GW572016 (lapatinib)
Intervention: Drug: GW572016 (lapatinib)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • WBC ≥ 3,000/mm^3
  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal
  • Alkaline phosphatase normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • PT/INR normal
  • Creatinine normal or Creatinine clearance ≥ 60 mL/min
  • Cardiac ejection fraction normal by echocardiogram or MUGA within the past 4 weeks
  • Prior radiotherapy, surgery or local ablative procedures as curative salvage therapy allowed
  • At least 1 year since prior neoadjuvant or adjuvant chemotherapy or hormonal therapy
  • At least 1 year since prior therapy that modulates testosterone levels (e.g., luteinizing hormone-releasing hormone agonists/antagonists or antiandrogens)
  • At least 1 year since prior investigational agents
  • More than 6 months since prior 5α-reductase inhibitors, megestrol, systemic steroids, ketoconazole or herbal supplements
  • At least 7 days to 6 months since prior CYP3A4 inducers or inhibitors as determined by the treating physician
  • Age 18 and over
  • ECOG Performance status 0-1
  • Able to swallow and retain oral medication
  • Fertile patients must use effective contraception

Exclusion Criteria:

  • Metastatic disease
  • Other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer
  • Unstable arrhythmias on ECG

    • Rate-controlled asymptomatic atrial fibrillation allowed
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • GI tract disease resulting in either of the following:

    • Malabsorption syndrome
    • Requirement for IV alimentation
  • Uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • Ongoing or active infection
  • Psychiatric illness or social situation that would preclude study compliance
  • History of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib
  • Other uncontrolled illness
  • Prior vaccine therapy or immunotherapy for prostate cancer
  • Prior surgery affecting gastrointestinal (GI) tract absorption
  • Concurrent ketoconazole
  • Concurrent CYP3A4 inducers or inhibitors
  • Concurrent antacids within 1 hour before or after study drug administration
  • Other concurrent investigational agents or anticancer therapy
  • Concurrent antiretroviral therapy for HIV-positive patients
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00103194
CDR0000409729, U10CA021115, ECOG-E5803
No
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Glenn Liu, MD University of Wisconsin, Madison
Eastern Cooperative Oncology Group
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP