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Recurrent Prostate CancerPhase 2NCT00103194

Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

A Phase 2 study testing lapatinib ditosylate and laboratory biomarker analysis in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
lapatinib ditosylate and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
Sep 2005to Jun 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of prostate cancer
  • Previous treatment with definitive surgery or radiation therapy
  • Prior salvage therapy (surgery, radiation, or other local ablative procedures) is allowed if the intent was for cure
  • No evidence of metastatic disease on physical exam, computed tomography (CT) (magnetic resonance imaging [MRI]), and bone scan
  • Prior neoadjuvant/adjuvant hormonal or chemotherapy and investigational agents are allowed if it was last used >= 1 year prior to enrollment (no prior vaccine/immunotherapy for prostate cancer will be allowed)
  • No therapy modulating testosterone levels (such as luteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 1 year prior to enrollment; agents such as 5alpha-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements are not permitted at any time during the period that the PSA values are being collected
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  • Hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL within 4 weeks prior to registration
  • All patients must have evidence of biochemical progression as determined by a reference PSA value followed by 2 rising PSA values, each higher than the previous value, obtained at least 6 weeks apart; all of these PSA values must be obtained at the same reference lab, and all must be done within 6 months prior to enrollment
  • The most recent of the PSA values must be greater than 0.4 ng/ml (after prostatectomy) or greater than 1.5 ng/ml (after radiation therapy) at time of enrollment; this measurement must be obtained within 6 months prior to enrollment
  • PSA doubling time (PSADT) must be =< 365 days
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Leukocytes >= 3000/mm^3
  • Granulocytes >= 1500/mm^3
  • Platelet count >= 100,000/mm^3
  • Serum creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Serum total bilirubin within normal institutional limits
  • Serum alkaline phosphatase within normal institutional limits
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x institutional upper limit of normal
  • Cardiac ejection fraction within the institutional range of normal, as measured by echocardiogram or multi gated acquisition scan (MUGA) scan within 4 weeks prior to registration; note that baseline and on-treatment scans should be performed using the same modality and preferably at the same institution
  • No unstable arrhythmias on electrocardiogram (ECG) are allowed (rate controlled, asymptomatic atrial fibrillation is allowed)
  • No concomitant use of any medication classified as cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor; for patients previously treated with one of these prohibited medications, the prohibited agent needs to be discontinued, either 7 days, 14 days, or 6 months prior to the administration of the first dose of study medication
  • Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
  • Normal prothrombin time (PT)/international normalized ratio (INR) within 4 weeks prior to registration
  • Able to swallow and retain oral medication
  • Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) will not be eligible
  • Sexually active males are strongly advised to use an accepted and effective method of contraception
  • Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016
  • No 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
  • No other malignancies permitted within the past 5 years with the exception of non-melanoma skin cancer treated with curative intent

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA

This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the percentage of patients with hormone sensitive prostate cancer who experience > 50% decline in serum PSA during treatment with GW572016 (lapatinib ditosylate).

SECONDARY OBJECTIVES:

  1. To evaluate the duration of PSA decline. II. To characterize the change in PSA slope with GW572016. III. To characterize the safety and tolerability of GW572016 in this patient population.

IV. To estimate the time to progression (TTP) and progression-free survival at 2 years (from start of therapy).

  1. To evaluate the correlation of epidermal growth factor receptor (EGFR) expression/signaling (from available prostate biopsy specimens or prostatectomy blocks) and its relationship to change in PSA in patients treated with GW572016.

OUTLINE:

Patients receive lapatinib ditosylate orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, or every year if patient is 5-10 years from study entry for 10 years.

Being tested
lapatinib ditosylate, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lapatinib ditosylateDrug

    Also called GSK572016, GW-572016, GW2016, Lapatinib

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00103194
Study groupRoleWhat they receive
Treatment (lapatinib ditosylate)ExperimentalPatients receive lapatinib ditosylate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: lapatinib ditosylate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level

    PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.

    CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.

    PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later.

    Measured: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Secondary outcomes (3)

  1. The Change in PSA Slope With GW572016 (Lapatinib)

    PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.

    Measured: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years

  2. Progression-free Survival Rate at 2 Years

    Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.

    Measured: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

  3. Relationship Between Progression-free Survival and EGFR Expression Levels

    The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.

    Measured: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103194
Sponsor's protocol ID
NCI-2014-01158
Other IDs
NCI-2014-01158, E5803, CDR0000409729, U10CA180820, U10CA021115
Status last verified
Jun 2014
First submitted
7 Feb 2005
Last updated
30 Sep 2014
Data monitoring committee
Yes

Publications

  • Liu G, Chen YH, Kolesar J, Huang W, Dipaola R, Pins M, Carducci M, Stein M, Bubley GJ, Wilding G. Eastern Cooperative Oncology Group Phase II Trial of lapatinib in men with biochemically relapsed, androgen dependent prostate cancer. Urol Oncol. 2013 Feb;31(2):211-8. doi: 10.1016/j.urolonc.2011.01.002. Epub 2011 Jul 23.

    PubMed 21784672

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib ditosylate and laboratory biomarker analysis in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level (time frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00103194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.

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