A Pilot Study of Tamoxifen, Carboplatin and Topotecan in the Treatment of Recurrent or Refractory Primary Brain or Spinal Cord Tumors or Metastatic Epithelial Cancers With Central Nervous System Metastases
- To evaluate the systemic and CNS response rates and progression-free and overall
survival of patients with epithelial cancer and brain metastases treated with tamoxifen
citrate, topotecan hydrochloride, and carboplatin.
- To evaluate the response rates, progression-free survival, and overall survival of
patients with recurrent primary glial tumors treated with this regimen.
- To further assess the toxicity of these drugs in these patients.
- To further evaluate the pharmacokinetics of topotecan hydrochloride and tamoxifen
citrate using paired specimens of cerebrospinal fluid and plasma from these patients.
OUTLINE: Patients are stratified by disease type (epithelial CNS metastases vs recurrent
Patients receive topotecan IV on days 1-3 (72 hours), carboplatin IV over 30 minutes on day
4, and oral tamoxifen twice daily on days 1-7. Treatment repeats every 28 days in the
absence of disease progression or unacceptable toxicity. Patients achieving a complete
response (CR) may be treated for 2 additional courses after documentation of CR.
Patients undergo blood sample collection at baseline and then periodically after the first
dose of topotecan to obtain plasma pharmacokinetic (PK) measurements of topotecan and
tamoxifen. Some patients may also undergo cerebrospinal fluid (CSF) collection to assess
peak CSF levels of topotecan and tamoxifen during course 1.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity profile as assessed by NCI CTC v2.0
All patients who complete one course of therapy and are followed a minimum of 3 weeks after completion of first course of therapy
Robert J. Morgan, MD
Beckman Research Institute
United States: Federal Government
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|