Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Tamoxifen may help carboplatin work better by making tumor cells more sensitive to
the drug.
PURPOSE: This phase II trial is studying the side effects of giving carboplatin and
topotecan together with tamoxifen and to see how well it works in treating patients with
central nervous system metastases or recurrent brain or spinal cord tumors.
OBJECTIVES:
- 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
glial tumors).
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
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