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Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident By a Rising PSA

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident By a Rising PSA



- 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).


- 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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level

Outcome Description:

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.

Outcome 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

Safety Issue:


Principal Investigator

Glenn Liu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

September 2005

Completion Date:

July 2009

Related Keywords:

  • Prostate Cancer
  • Recurrent prostate cancer
  • GW572016
  • lapatinib
  • Prostatic Neoplasms