Pharmacokinetics Study of Combined Treatment Lapatinib and Tamoxifen in Advanced/Metastatic Breast Cancer
Overview
- Phase
- Phase 1
- Intervention
- lapatinib ditosylate
- Conditions
- Breast Cancer
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer.
PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and tamoxifen in treating patients with advanced or metastatic breast cancer.
Detailed Description
OBJECTIVES: Primary * Determine the pharmacokinetics of lapatinib ditosylate and tamoxifen citrate in patients with advanced or metastatic breast cancer. Secondary * Assess the safety of this regimen in these patients. * Determine any relationship between drug exposure and adverse events or biological modifications of this regimen in these patients. * Assess the antitumor activity of this regimen in patients with measurable disease. OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral tamoxifen citrate on days 1-28 of course 1. In all subsequent courses, patients receive oral tamoxifen citrate and oral lapatinib ditosylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral lapatinib ditosylate on days 1-14 of course 1. In all subsequent courses, patients receive oral lapatinib ditosylate and oral tamoxifen citrate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. In both treatment arms, blood is collected periodically during courses 1 and 2 for pharmacokinetic studies. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Tamoxifen-lapatinib
Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.
Intervention: lapatinib ditosylate
Tamoxifen-lapatinib
Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.
Intervention: tamoxifen citrate
Tamoxifen-lapatinib
Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.
Intervention: pharmacological study
Lapatinib-tamoxifen
Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen
Intervention: lapatinib ditosylate
Lapatinib-tamoxifen
Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen
Intervention: tamoxifen citrate
Lapatinib-tamoxifen
Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen
Intervention: pharmacological study
Outcomes
Primary Outcomes
Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination
Time Frame: maximum 24h after the dose administered on Day 28
Secondary Outcomes
- Safety(until disease progression or until the start of another treatment (average 2 months))
- Relationship between drug exposure and adverse events or biological modifications(until disease progression or until the start of another treatment (average 2 months))
- Response in patients with measurable disease(until disease progression or until the start of another treatment (average 2 months))