Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

• Determine the antitumor activity of lapatinib, in terms of objective response rate (partial response [PR] and complete response [CR]), in patients with recurrent and/or metastatic adenoid cystic carcinoma of the salivary gland.

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 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 symptomatic brain metastases

• Patients with known brain metastases that have been stable ≥ 3 months since completion of radiotherapy or surgery and who have no significant neurological deficits and are off corticosteroids are eligible

• 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

• Able to swallow and retain oral medication

• No gastrointestinal disease resulting in an inability to take oral medication

• No malabsorption syndrome

• No requirement for IV alimentation

• No uncontrolled inflammatory gastrointestinal disease (e.g., Crohn's disease or ulcerative colitis)

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Princess Margaret Hospital

Lillian L. Siu

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095563
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top