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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of GW572016 in Recurrent and/or Metastatic Adenoid Cystic Carcinoma, and Other EGFR-and/or erbB2-expressing Malignant Tumors of the Salivary Glands

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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the antitumor activity of GW572016 in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands using objective response rates (partial and complete responses).

SECONDARY OBJECTIVES:

I. To determine the duration of objective response, rate and duration of stable disease, progression-free, median and overall survival rates of GW572016 in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands.

II. To estimate the antitumor activity of GW572016 in other epidermal growth factor receptor (EGFR)- and/or erbB2-overexpressing malignant tumors of the salivary glands using objective response rates (partial and complete responses).

III. To document the safety and tolerability of GW572016 in these patient populations

TERTIARY OBJECTIVES:

I. To investigate if differences in baseline levels of EGFR and/or erbB2 expression, and receptor phosphorylation status in tumor specimens predict outcome to therapy.

II. To investigate if the inhibitory effects of GW572016 on EGFR and/or erbB2 pathway activation in tumor specimens correlate with clinical outcome.

III. To determine the steady state levels of GW572016 achieved, and their correlation with clinical and laboratory correlative endpoints.

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

Patients receive oral lapatinib once daily on days 1-28. Courses repeat e
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Objective Response Rates (Partial and Complete Responses) [ Time Frame: Up to 5 years ]

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;


Original Primary Outcome:

Current Secondary Outcome:

  • Duration of Objective Response [ Time Frame: 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 [ Time Frame: 6 months ]
    Number of patients who had Stable disease for more than or equal to 6 months together in both Adenoid cystic carcinoma (ACC) and non-adenoid cyctic carcinoma (non-ACC)
  • Progression-free Survival (PFS) According to RECIST [ Time Frame: 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) [ Time Frame: From the date of study enrolment to death or last contact, assessed up to 5 years ]
    Survival estimates will be computed using the Kaplan-Meier method.
  • Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading [ Time Frame: Up to 5 years ]
    Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 5, 2004
Date Started: September 2004
Date Completion:
Last Updated: March 6, 2017
Last Verified: March 2017