Clinical Trial: Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers

This study is currently recruiting patients.

Sponsors and Collaborators: Princess Margaret Hospital
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers.

Condition Treatment or Intervention Phase
high-grade salivary gland carcinoma
low-grade salivary gland carcinoma
Salivary Gland Cancer
 Drug: lapatinib
 Procedure: enzyme inhibitor therapy
 Procedure: protein tyrosine kinase inhibitor therapy
Phase II

MedlinePlus related topics:  Oral Cancer;   Salivary Gland Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Lapatinib in Patients With Recurrent and/or Metastatic Adenoid Cystic Carcinoma or Other Epidermal Growth Factor Receptor- and/or ERBB2-Overexpressing Malignant Tumors of the Salivary Gland

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine the duration of objective response in patients treated with this drug.
  • Determine the rate and duration of stable disease in patients treated with this drug.
  • Determine progression-free, median, and overall survival of patients treated with this drug.
  • Determine the antitumor activity of this drug, in terms of objective response rate (PR and CR), in patients with other epidermal growth factor receptor- and/or ERBB2-overexpressing malignant tumors of the salivary gland.
  • Determine the safety and tolerability of this drug in these patient populations.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

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

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 12-67 patients (12-37 patients with adenoid cystic carcinoma [ACC] of the salivary gland and a maximum of 30 patients with epidermal growth factor receptor- or ERBB2-expressing non-ACC of the salivary gland) will be accrued for this study within 18 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenoid cystic or other malignant salivary gland carcinoma of major or minor salivary gland origin, meeting 1 of the following criteria:
  • Epidermal growth factor receptor (EGFR) expressing tumors
  • ERBB2 expressing tumors
  • Recurrent and/or metastatic disease
  • Progressive disease as defined by 1 of the following criteria occurring within in the past 6 months:
  • At least a 20% increase in radiologically or clinically measurable disease
  • Appearance of any new lesions
  • Deterioration in clinical status
  • Not amenable to surgery or curative radiotherapy
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Lesion must be outside of field of prior local therapy OR disease has progressed within the treatment field
  • No known brain metastases
  • Tumor lesions accessible for biopsy
  • In the event that tumor biopsy is medically contraindicated exceptions may be granted by the Principal Investigator only

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 12 weeks

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • Cardiac ejection fraction normal by echocardiogram or MUGA
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Gastrointestinal

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing and able to undergo tumor biopsy (unless medically contraindicated)
  • No other active malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib
  • No other uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy, except low-dose, non-myelosuppressive radiotherapy

Surgery

  • No prior gastrointestinal surgical procedures affecting absorption
  • At least 4 weeks since prior surgery

Other

  • Recovered from all prior therapy
  • No prior EGFR or ERBB2-targeting therapies
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors
  • At least 7 days since prior and no concurrent proton-pump inhibitors or H_2 inhibitors
  • At least 14 days since prior and no concurrent CYP3A4 inducers
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Location and Contact Information


Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States; Recruiting
Robert F. Marschke, MD  480-301-8335 

District of Columbia
      Howard University Cancer Center at Howard University Hospital, Washington,  District of Columbia,  20060,  United States; Recruiting
Fitzroy Winston Dawkins, MD  202-865-6625 ext. 1875    fdawkins@howard.edu 

Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
William J. Maples, MD  904-953-8548    maples.william@mayo.edu 

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting
Patrick J. Stiff, MD  708-327-3300 

      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States; Recruiting
Edem S. Agamah, MD, MS  217-525-2500    ihdn@aol.com 

      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6600 

      Evanston Northwestern Health Care - Evanston Hospital, Evanston,  Illinois,  60201-1781,  United States; Recruiting
Bruce E. Brockstein, MD  847-570-2515    b-brockstein@northwestern.edu 

      Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey,  Illinois,  60426,  United States; Recruiting
Mark F. Kozloff, MD  708-339-4800    mfkozloff@aol.com 

      Oncology/Hematology Associates of Central Illinois, P.C., Peoria,  Illinois,  61615-7828,  United States; Recruiting
John W. Kugler, MD  309-671-5180    jkugler@ohaci.com 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Ezra Cohen, MD  773-702-4400    ecohen@medicine.bsd.uchicago.edu 

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
David Allen Taber, MD  574-284-7370 

      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
David Frank Sciortino, MD  260-484-8830 

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Gerald H. Clamon, MD  319-356-8110 

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting
Manuel Hidalgo, MD, PhD  410-502-3850    mhidalg1@jhmi.edu 

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Patricia M. LoRusso, DO  313-745-8296 

      Oncology Care Associates, P.L.L.C., Saint Joseph,  Michigan,  49085,  United States; Recruiting
Eric P. Lester, MD  269-985-0029    oncology@parrett.net 

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Scott Okuno, MD  507-284-2511    okuno.scott@mayo.edu 

Missouri
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Paula M. Fracasso, MD, PhD  314-454-8817 

Wisconsin
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Stuart J. Wong, MD  414-805-4603 

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States; Recruiting
Jim Cleary, MD  608-265-8047    jfcleary@wisc.edu 

Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
Eric Winquist, MD  519-685-8640 ext. 53243 

      Margaret and Charles Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada; Recruiting
Sebastien Hotte, MD  905-387-9495, ext. 64784    sebastien.hotte@hrcc.on.ca 

      Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting
Glenwood Dillon Goss, MD, BCh, FCP, FRCPC  613-737-7700 ext. 56708 

      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting
Lillian L. Siu, MD, FRCPC  416-946-2911 

Study chairs or principal investigators

Lillian L. Siu, MD, FRCPC,  Principal Investigator,  Princess Margaret Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000394174; PMH-PHL-028; NCI-6701; NCT00095563
Record last reviewed:  November 2004
Last Updated:  April 4, 2005
Record first received:  November 5, 2004
ClinicalTrials.gov Identifier:  NCT00095563
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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