Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer (NCT00095667) | Clinical Trial Compass
CompletedPhase 2
Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer
Canada41 participantsStarted 2004-11
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Must b…
What they're measuring
1
PSA response rate defined as at least a 50% fall in PSA from baseline confirmed by a second PSA 4 weeks later