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

NCT00103194 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2014-01158E5803CDR0000409729U10CA180820U10CA021115
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  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)

• The Change in PSA Slope With GW572016 (Lapatinib)

  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

• Progression-free Survival Rate at 2 Years

  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

• Relationship Between Progression-free Survival and EGFR Expression Levels

  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

Study Arms (1)

Treatment (lapatinib ditosylate)

EXPERIMENTAL

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

Drug: lapatinib ditosylate; Other: laboratory biomarker analysis

Interventions

lapatinib ditosylate DRUG

Given PO

Also known as: GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

Treatment (lapatinib ditosylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (lapatinib ditosylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

• 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.

  PMID: 21784672 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lapatinib; N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine

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: "Study Statistician"
• Organization: "ECOG Statistical Office"

617-632-3012

Study Officials

• Glenn Liu

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 30, 2014
• Results First Posted: April 13, 2012

Record last verified: 2014-06

Locations

US (1)