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Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer

NCT00246753•UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

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 prostate cancer that did not respond to hormone therapy.

Detailed Description

OBJECTIVES: Primary * Determine the proportion of patients with hormone-refractory prostate cancer who experience \> 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate. Secondary * Determine the safety of this drug in these patients. * Determine the time to PSA progression in patients treated with this drug. * Determine the molecular correlates and predictive biomarkers of response in patients treated with this drug. OUTLINE: This is a multicenter, open-label study. Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Serum samples are collected for biomarker analysis at baseline and every 4 weeks. After completion of study treatment, patients are followed at 4 weeks.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
•On androgen deprivation therapy for prostate cancer (either bilateral orchiectomy or medical castration with the testosterone level of \<50 ng/dl)
•Biochemical progression on androgen deprivation therapy with minimum PSA of 5 ng/ml. Progression is defined as two successive rises in PSA, measured at least one week apart. See section 4.1 for additional criteria.
•Minimum of 4-6 weeks off anti-androgen therapy (4 weeks for flutamide, 6 weeks for bicalutamide and nilutamide).
•Minimum of 4 weeks off other hormonal therapy (i.e. ketoconazole, megestrol acetate, aminoglutethimide)
•Minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other investigational agent.
•Patients must discontinue use of any herbal supplements prior to study initiation.
•No prior or concurrent exposure to cytotoxic chemotherapy.
•Age \> 18 years.
•Life expectancy greater than 12 weeks
+5 more criteria

Exclusion Criteria

•Patients who have had prior treatment with ErbB family targeting therapies.
•Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
•Prior chemotherapy for prostate cancer
•Patients with known brain metastases
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.
•Uncontrolled inter-current 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.
•A history of a positive HIV test in the past.
•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 inducers or inhibitors (please refer to section 3.2.2 for a list of medications).

Locations (3)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, United States

Key Dates

Start Date

October 1, 2005

Primary Completion Date

July 1, 2012

Completion Date

May 1, 2013

Last Updated

June 28, 2017

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

lapatinib ditosylate

DRUG

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC