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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lapatinib ditosylate
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 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. 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).

Sites / Locations

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Duke Comprehensive Cancer Center
  • Rex Cancer Center at Rex Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm Trial

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Prostate-Specific Antigen (PSA) Progression
Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.
Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)
To assess the correlation between expression of molecular markers and patient response to treatment with GW572016

Full Information

First Posted
October 28, 2005
Last Updated
May 26, 2017
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00246753
Brief Title
Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Acronym
NRR
Official Title
A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Trial
Arm Type
Other
Arm Description
Single Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
lapatinib ditosylate
Other Intervention Name(s)
GW572016
Intervention Description
1500 mg, daily until disease progression
Primary Outcome Measure Information:
Title
Number of Patients Experiencing Decline in Prostate-specific Antigen
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Time to Prostate-Specific Antigen (PSA) Progression
Description
Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.
Time Frame
4 years
Title
Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)
Description
To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
Time Frame
4 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Whang, MD, PhD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Rex Cancer Center at Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.gov/ct2/show/NCT00246753?term=LCCC0505&rank=1
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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