Tamoxifen, Carboplatin, and Topotecan in Treating Patients With CNS Metastases or Recurrent Brain or Spinal Cord Tumors
This study has been completed.
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00541138
First received: October 5, 2007
Last updated: September 20, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: carboplatin Drug: tamoxifen citrate Drug: topotecan hydrochloride Other: pharmacological study |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Tamoxifen
Carboplatin
Tamoxifen citrate
Topotecan hydrochloride
Topotecan
U.S. FDA Resources
Further study details as provided by City of Hope Medical Center:
Primary Outcome Measures:
- Toxicity profile as assessed by NCI CTC v2.0 [ 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 ] [ Designated as safety issue: Yes ]
- Response rate in patients with recurrent glial tumors as assessed by RECIST criteria [ Time Frame: All patients who complete at least one cycle of treatment ] [ Designated as safety issue: No ]
- Response rate in patients with epithelial CNS metastases as assessed by RECIST criteria [ Time Frame: All patients who complete at least one cycle of treatment ] [ Designated as safety issue: No ]
- Reason for going off-study [ Time Frame: Reported for all eligible patients ] [ Designated as safety issue: No ]
- Progression [ Time Frame: Reported for all eligible patients ] [ Designated as safety issue: No ]
- Survival [ Time Frame: Reported for all eligible patients ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2003 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: carboplatin
CBDCA AUC=3
Drug: tamoxifen citrate
Tamoxifen 100mg bid
Drug: topotecan hydrochloride
Topotecan 0.75 g/m2/d
Other: pharmacological study
Start of tx, hours 24,28 and 72 during Topotecan infusion, and hours 1,2,4 and 6 after end of Topotecan infusion.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541138
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
Sponsors and Collaborators
City of Hope Medical Center
Investigators
| Principal Investigator: | Robert J. Morgan, MD | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00541138 History of Changes |
| Other Study ID Numbers: | 02191, P30CA033572, CHNMC-02191, CDR0000570253 |
| Study First Received: | October 5, 2007 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by City of Hope Medical Center:
|
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 |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Nervous System Neoplasms Spinal Cord Neoplasms Central Nervous System Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Nervous System Diseases Spinal Cord Diseases Central Nervous System Diseases Tamoxifen Carboplatin Topotecan |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013