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

NCT00095563 | Completed Phase 2 Results

• 5 other identifiers: NCI-2012-030896701PHL-028N01CM62201N01CM62203
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

High-grade Salivary Gland Carcinoma; High-grade Salivary Gland Mucoepidermoid Carcinoma; Low-grade Salivary Gland Carcinoma; Low-grade Salivary Gland Mucoepidermoid Carcinoma; Recurrent Adenoid Cystic Carcinoma of the Oral Cavity; Recurrent Salivary Gland Cancer; Salivary Gland Acinic Cell Tumor; Salivary Gland Adenocarcinoma; Salivary Gland Adenoid Cystic Carcinoma; Salivary Gland Malignant Mixed Cell Type Tumor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rates (Partial and Complete Responses)

  Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions;

  Up to 5 years

Secondary Outcomes (5)

• Duration of Objective Response

  From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years

• Rate of Stable Disease

  6 months

• Progression-free Survival (PFS) According to RECIST

  From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years

• Overall Survival (OS)

  From the date of study enrolment to death or last contact, assessed up to 5 years

• Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading

  Up to 5 years

Study Arms (1)

Treatment (lapatinib ditosylate)

EXPERIMENTAL

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

Drug: lapatinib ditosylate; Other: laboratory biomarker analysis

Interventions

lapatinib ditosylate DRUG

Given orally

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

You may qualify if:

• Patients must have histologically documented or cytologically confirmed adenoid cystic, or other malignant salivary gland carcinomas of major or minor salivary gland origin; all patients must have either EGFR and/or erbB2 expressing tumors (for definitions of EGFR and erbB2 expression to be enrolled in this study; EGFR and erbB2 expression will be determined using archival paraffin samples for all study patients where possible; if these samples are unavailable then patients must undergo a biopsy to determine their EGFR and erbB2 status
• Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy; progressive disease is defined as one of the following occurring within 6 months of study entry:
• At least a 20% increase in radiologically or clinically measurable disease
• Appearance of any new lesions or
• Deterioration in clinical status
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
• Patients may have had unlimited prior therapy; however, there must be at least a 4 weeks' interval between any chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and study enrollment; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy - please contact the Principal Investigator (Dr. L. Siu) PRIOR to registration if questions arise about the interpretation of this criterion; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
• Life expectancy of greater than 12 weeks
• ECOG performance status 0,1, or 2
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,5000/uL
• Platelets \>= 100,000/uL
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) =\< 2.5 x institutional upper limit of normal
• Creatinine within normal institutional limits OR

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or
• Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients who have had prior treatment with EGFR or erbB2 targeting therapies
• Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
• Patients with known brain metastases but have remained stable for at least 3 months since completion of radiotherapy or surgery, have no significant neurological deficits, and are off corticosteroids, may be allowed on study; patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non-melanomatous skin cancers) are excluded
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because GW572016 is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects; breastfeeding should be discontinued if the mother is treated with GW572016
• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
• Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
• Concomitant requirement for medication classified as CYP3A4 inducer or inhibitor

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Lillian Siu
• Organization: Princess Margaret Cancer Centre

lillian.siu@uhn.ca

416-946-2911

Study Officials

• Lillian Siu

  Princess Margaret Hospital Phase 2 Consortium

  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: November 5, 2004
• First Posted: November 8, 2004
• Study Start: September 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 18, 2017
• Results First Posted: April 18, 2017

Record last verified: 2017-03

Locations

CA (1)