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

NCT00246753 | Completed Phase 2 Results DMC

• 2 other identifiers: LCCC 0505CDR0000550151
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing Decline in Prostate-specific Antigen

  Determine the number of patients with hormone-refractory prostate cancer who experience \> 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.

  4 years

Secondary Outcomes (2)

• Time to Prostate-Specific Antigen (PSA) Progression

  4 years

• Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)

  4 years

Study Arms (1)

Single Arm Trial

OTHER

Single Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity.

Drug: lapatinib ditosylate

Interventions

lapatinib ditosylate DRUG

1500 mg, daily until disease progression

Also known as: GW572016

Single Arm Trial

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 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or multigated acquisition scan (MUGA) scan.
• Men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation since the effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown.
• Ability to swallow and retain oral medication.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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).

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• GlaxoSmithKline: collaborator

Study Sites (3)

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

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lapatinib

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

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Young Whang, MD, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2013
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-05

Locations

US (3)