Randomized RT +/- Lapatinib for Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease

NCT01427322 | Terminated Early Phase 1 DMC

• 2 other identifiers: MCC-13711NCI-2011-02734
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

Lapatinib will prevent radiation-induced increase in Transforming Growth Factor alpha (TGFα), an important growth factor in cancer cell recovery after ionizing irradiation.

Conditions

Epithelial Cancer

Keywords

lapatinib; radiation therapy; metastases

Outcome Measures

Primary Outcomes (1)

• TGFalpha

  Blockade of the ERBB1 receptor will abrogate increases in TGFalpha in response to radiation therapy. We will compare serum changes in TGFalpha between the lapatinib and control groups for patients receiving radiotherapy for stage IV epithelial-derived cancer.

  3 years

Study Arms (2)

lapatinib + radiation therapy

EXPERIMENTAL

lapatinib given orally 2-4 hours prior to first fraction of radiation

Drug: Lapatinib; Radiation: Radiation therapy

No therapy prior to radiation

ACTIVE COMPARATOR

Radiation therapy alone

Radiation: Radiation therapy

Interventions

Lapatinib DRUG

given orally 2-4 hours before first fraction of radiation therapy

Also known as: GW572016, Tykerb

lapatinib + radiation therapy

Radiation therapy RADIATION

Standard radiation therapy

No therapy prior to radiation; lapatinib + radiation therapy

Eligibility Criteria

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

You may qualify if:

• History of stage IV epithelial-derived cancer requiring palliative radiation. Patients with sarcoma, lymphoma, myeloma or neuroendocrin cancers are not eligible.
• Evidence of metastatic disease
• Recommendation by patient's radiation oncologist to receive palliative external beam radiation for metastases -- minimum fraction size of 3 Gy.
• Age 18 years or older
• Patients may be undergoing concurrent therapy with GNRH agonists or combined androgen blockade or anti-estrogen hormonal therapy for breast cancer, as these are standard care for advanced prostate and some breast cancers respectively.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Any contraindication to lapatinib treatment.
• Prior radiation therapy within 30 days of the start of the planned course of treatment.
• Prior cytotoxic chemotherapy within 4-2 weeks of planned first dose of radiation. Persistent grade 2 or greater non-hematologic toxicity (other than neuropathy) from cytotoxic chemotherapy regardless of interval since last dose. Persistent grade 3 or greater hematologic toxicity (other than lymphopenia) reglardless of interval since last dose.
• 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.
• Pregnant or nursing. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment. Women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation. Men must agree to use a medically accepted form of birth control for 4 months following completion of study treatment.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Massey Cancer Center, Virginia Commonwealth University

Richmond, Virginia, 23298-0037, United States

Location

Related Links

• Massey Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Lapatinib; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Andrew S. Poklepovic, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

US (2)