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Brain and Central Nervous System TumorsPhase 2NCT00541138

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

A Phase 2 study testing carboplatin, tamoxifen citrate and topotecan hydrochloride in people with Brain and Central Nervous System Tumors and Metastatic Cancer, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carboplatin, tamoxifen citrate and topotecan hydrochloride
Type of treatment
Injection or infusion
How many people
50 participants
Where
1 siteUnited States
Study dates
May 2003to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

Other trials in United States

About this study

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.

Read the 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.

Being tested
carboplatin, tamoxifen citrate, topotecan hydrochloride, pharmacological study
Keywords
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
Medical subject headings
Central Nervous System Neoplasms, Neoplasm Metastasis, Brain Neoplasms, Astrocytoma, Glioblastoma, Gliosarcoma, Ependymoma, Glioma, Subependymal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

    CBDCA AUC=3

  • tamoxifen citrateDrug

    Tamoxifen 100mg bid

  • topotecan hydrochlorideDrug

    Topotecan 0.75 g/m2/d

  • pharmacological studyOther

    Start of tx, hours 24,28 and 72 during Topotecan infusion, and hours 1,2,4 and 6 after end of Topotecan infusion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity profile as assessed by NCI CTC v2.0

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

  2. Response rate in patients with recurrent glial tumors as assessed by RECIST criteria

    Measured: All patients who complete at least one cycle of treatment

  3. Response rate in patients with epithelial CNS metastases as assessed by RECIST criteria

    Measured: All patients who complete at least one cycle of treatment

  4. Reason for going off-study

    Measured: Reported for all eligible patients

  5. Progression

    Measured: Reported for all eligible patients

  6. Survival

    Measured: Reported for all eligible patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2007 (estimated)
  2. Study startMay 2003
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00541138
Sponsor's protocol ID
02191
Other IDs
P30CA033572, CHNMC-02191, CDR0000570253
Status last verified
Sep 2011
First submitted
5 Oct 2007
Last updated
21 Sep 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, tamoxifen citrate and topotecan hydrochloride in people with Brain and Central Nervous System Tumors and Metastatic Cancer, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00541138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.

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