Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer

NCT00095667 | Completed Phase 2

• 4 other identifiers: NCI-2012-03178PHL-030CDR394173N01CM62203
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.

Conditions

Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA response rate defined as at least a 50% fall in PSA from baseline confirmed by a second PSA 4 weeks later

  Up to 3 years

Secondary Outcomes (6)

• Objective tumor response

  Up to 3 years

• Duration of PSA response

  Up to 3 years

• Rate and duration of stable disease

  From the start of the treatment until the criteria for progression are met, assessed up to 3 years

• Progression-free survival

  From start of treatment to time criteria are met for disease progression, assessed up to 3 years

• Overall survival

  Up to 3 years

Study Arms (1)

Treatment (lapatinib ditosylate)

EXPERIMENTAL

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

Drug: lapatinib ditosylate; Other: laboratory biomarker analysis

Interventions

lapatinib ditosylate DRUG

Given orally

Also known as: GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

Treatment (lapatinib ditosylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (lapatinib ditosylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed prostate cancer that is recurrent after local therapy, and/or metastatic carcinoma confirmed to be of prostate origin
• Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy; progressive disease is defined as:
• Three consecutive rising PSAs, at least 4 weeks apart with an absolute increase of at least 0.5
• PSA doubling time of less than one year
• PSA \> 2.0
• For recurrent disease following local therapy (surgery/radiation), prior neoadjuvant or adjuvant hormones are allowed if completed more than a year prior to study entry; for metastatic disease, no prior medical therapy (hormonal, corticosteroid, chemotherapy) is allowed
• Life expectancy of greater than 12 weeks
• ECOG performance status 0,1, or 2
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 100,000/uL
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) =\< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits or creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan; note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution

You may not qualify if:

• Prior treatment:
• Patients who have had prior chemotherapy for prostate cancer
• Patients who have been on androgen ablative therapies within the last year
• Patients receiving radiotherapy to the prostate less than 6 weeks prior to study entry
• Patients who have had prior treatment with EGFR targeting therapies
• Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
• Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated non-melanomatous skin cancers) are excluded
• History of allergic reactions attributed to compounds of similar chemical or biological composition to GW572016
• Uncontrolled intercurrent 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
• Patients with cardiac ejection fraction, not within the institutional range of normal as measured by echocardiogram or MUGA scan at baseline
• 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 inducer or inhibitor

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lapatinib; N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John Trachtenberg

  Princess Margaret Hospital Phase 2 Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2004
• First Posted: November 8, 2004
• Study Start: November 1, 2004
• Primary Completion: November 1, 2007
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

CA (1)