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A Randomized Study of Lapatinib With Radiation Versus Radiation Alone in Prostate Cancer Patients Receiving Radiation Therapy for Bone Metastases


Phase 0
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Randomized Study of Lapatinib With Radiation Versus Radiation Alone in Prostate Cancer Patients Receiving Radiation Therapy for Bone Metastases


Lapatinib is an orally bioavailable small molecule inhibitor of ERBB1 and ERBB2 (HER2). It
is currently indicated for use in patients with HER2 over-expressing metastatic breast
cancer. Serum increases in TGFα can have growth potentiating effects on distant sites of
metastatic disease. Palliative irradiation paradoxically may promote distant tumor growth;
blocking shedding of TGFα from irradiated tumors may prevent this effect and improve the
therapeutic index of radiation therapy.


Inclusion Criteria:



- History of adenocarcinoma of the prostate

- Evidence of metastatic disease

- Recommendation by patient's radiation oncologist to receive palliative external beam
radiation for bone metastases secondary to metastatic prostate cancer

- Age 18 years or older

- Patients may be undergoing concurrent therapy with GNRH agonists or combined androgen
blockade, as this is standard care for all advanced prostate cancers

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Any contraindication to lapatinib treatment.

- Prior radiation therapy within 30 days of the start of the planned course of
treatment.

- Prior cytotoxic chemotherapy within 4 weeks of planned first dose of radiation.

- Prior administration of an ERBB1 or ERK1/2 inhibitor within 30 days of the start of
the planned course of treatment.

- Patients with a medical necessity to continue active therapy with CYP3A4 strong
inhibitors or inducers. The concomitant use of strong CYP3A4 inhibitors should be
avoided (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir,
nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole,
aprepitant). Grapefruit may also increase plasma concentrations of lapatinib and
should be avoided. Once the strong inhibitor or inducer is discontinued, a washout
period of approximately 1 week should be allowed before the lapatinib administration.
If a patient is unable to discontinue these medications, they are not eligible for
enrollment.

- Concurrent administration of any other investigational agents.

- Uncontrolled concurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, active hepatic or biliary disease with a Child-Pugh class of B or C, or
psychiatric illness/social situations that would limit compliance with study
requirements or that would interfere with accomplishing the study objectives.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

TGFalpha

Outcome Description:

Blockade of the ERBB1 receptor will abrogate increases in TGFalpha in response to radiation therapy

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Andrew S. Poklepovic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

MCC-13711

NCT ID:

NCT01427322

Start Date:

September 2011

Completion Date:

August 2014

Related Keywords:

  • Prostate Cancer
  • lapatinib
  • radiation therapy
  • prostate cancer
  • bone metastases
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Massey Cancer Center, Virginia Commonwealth UniversityRichmond, Virginia  23298