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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Epithelial neoplasms metastatic to the central nervous system

- Recurrent or refractory to prior chemotherapeutic or radiotherapeutic
regimens or for which no standard chemotherapy or whole brain radiotherapy
regimens exist

- Stage IV disease

- Recurrent glial tumors (brain or spinal cord)

- Received prior whole brain radiotherapy or stereotactic radiotherapy OR refused
radiotherapy

- Patients with CNS metastases previously treated with radiotherapy are eligible,
provided persistent or progressive CNS metastases are documented by MRI eight
weeks after the end of radiotherapy

- Patients with glial tumors must show progressive disease by MRI after prior
radiotherapy

- Measurable disease in the brain/leptomeninges of the brain or spinal cord with
baseline documentation within 4 weeks of study entry

- Must have ≥ 1 lesion that is ≥ 1 cm on MRI scan

- Ineligible for or has refused participation in higher priority institutional
protocols

PATIENT CHARACTERISTICS:

- Karnofsky performance status 50-100%

- Life expectancy ≥ 2 months

- Creatinine ≤ 1.5 mg/dL

- WBC 4,000/mm³ OR ANC ≥ 2,000/mm³

- Platelet count ≥ 150,000/mm³

- Bilirubin ≤ 1.5 mg/dL

- ALT and AST < 2 times upper limit of normal

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No nonmalignant concurrent illness (e.g., cardiovascular or pulmonary) that is either
poorly controlled with currently available treatment or of such severity to preclude
study entry

- No severe infection

- Patients who are ineligible for lumbar puncture are allowed

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy, immunotherapy, or chemotherapy OR
recovered from expected side effects of prior therapy

- No patients who are recovering from major surgery

- No concurrent radiotherapy

- Concurrent steroid or anticonvulsant therapy allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity profile as assessed by NCI CTC v2.0

Outcome Time Frame:

All patients who complete one course of therapy and are followed a minimum of 3 weeks after completion of first course of therapy

Safety Issue:

Yes

Principal Investigator

Robert J. Morgan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

02191

NCT ID:

NCT00541138

Start Date:

May 2003

Completion Date:

October 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • tumors metastatic to brain
  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • adult diffuse astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pilocytic astrocytoma
  • adult pineal gland astrocytoma
  • adult subependymal giant cell astrocytoma
  • adult brain stem glioma
  • adult anaplastic ependymoma
  • adult ependymoma
  • adult myxopapillary ependymoma
  • adult subependymoma
  • adult anaplastic oligodendroglioma
  • adult oligodendroglioma
  • unspecified adult solid tumor, protocol specific
  • adult mixed glioma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Spinal Cord Neoplasms
  • Central Nervous System Neoplasms

Name

Location
City of Hope Comprehensive Cancer Center Duarte, California  91010