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Tamoxifen, Carboplatin, and Topotecan in Treating Patients With CNS Metastases or Recurrent Brain or Spinal Cord Tumors

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ClinicalTrials.gov Identifier: NCT00541138
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : September 21, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 8, 2007
Last Update Posted Date September 21, 2011
Study Start Date  ICMJE May 2003
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
  • 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 ]
  • 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 ]
  • 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 ]
  • Reason for going off-study [ Time Frame: Reported for all eligible patients ]
  • Progression [ Time Frame: Reported for all eligible patients ]
  • Survival [ Time Frame: Reported for all eligible patients ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
  • Toxicity profile as assessed by NCI CTC v2.0
  • Response rate in patients with recurrent glial tumors as assessed by RECIST criteria
  • Response rate in patients with epithelial CNS metastases as assessed by RECIST criteria
  • Reason for going off-study
  • Progression
  • Survival
Change History Complete list of historical versions of study NCT00541138 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tamoxifen, Carboplatin, and Topotecan in Treating Patients With CNS Metastases or Recurrent Brain or Spinal Cord Tumors
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 5, 2007)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541138
Other Study ID Numbers  ICMJE 02191
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-02191
CDR0000570253 ( Registry Identifier: NCI PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Robert J. Morgan, MD City of Hope Comprehensive Cancer Center
PRS Account City of Hope Medical Center
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP