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Recurrent Breast CancerPhase 1/2NCT00054028

Suramin and Paclitaxel in Treating Women With Stage IIIB-IV Breast Cancer

A Phase 1/2 study testing suramin, paclitaxel and pharmacological study in people with Recurrent Breast Cancer and Stage IIIB Breast Cancer, run by National Cancer Institute (NCI) 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

This phase I/II trial studies the best dose of suramin when given together with paclitaxel in treating women with stage IIIB-IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
suramin, paclitaxel and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
Dec 2002to Mar 2008
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed stage IIIB or IV metastatic breast cancer (MBC)
  • Prior chemotherapy:
  • Phase I: patients must have received prior paclitaxel or other taxanes in either the adjuvant or metastatic setting; prior chemotherapy, radiation or surgery must be completed at least 21 days before study entry; prior treatment with anthracyclines is not required
  • Phase II: up to two prior chemotherapy regimens for stage IIIB or IV MBC; patients must have received prior paclitaxel or other taxanes in either the adjuvant or metastatic setting; prior chemotherapy, radiation or surgery must be completed at least 21 days before study entry; prior treatment with anthracyclines is not required
  • Measurable disease (phase II)
  • No known brain metastases
Show all 40Show fewer
  • Hormone receptor status:
  • Not specified
  • Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
  • White blood cell (WBC) at least 3,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL
  • Bilirubin no greater than 1.5 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal
  • Creatinine no greater than 1.5 mg/dL
  • Left ventricular ejection fraction (LVEF) at least lower limit of normal
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributable to compounds of similar chemical or biological composition to Cremophor
  • No concurrent uncontrolled illness that would preclude study compliance
  • No ongoing or active infection
  • No uncontrolled diabetes mellitus
  • No psychiatric illness or social situations that would preclude study compliance
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No more than 2 prior chemotherapy regimens for this malignancy (phase II)
  • No concurrent steroids or hormones except the following:
  • Steroids to prevent hypersensitivity reactions prior to paclitaxel administration
  • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
  • At least 3 weeks since prior radiotherapy and recovered
  • At least 3 weeks since prior surgery and recovered
  • No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
  • No other concurrent investigational agents
  • Concurrent bisphosphonates (i.e., pamidronate or zoledronate) are allowed for the treatment of hypercalcemia or palliation of skeletal metastases

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase I/II Study of Suramin in Combination With Paclitaxel in Advanced (Stage IIIB or IV) Metastatic Breast Cancer

This phase I/II trial studies the best dose of suramin when given together with paclitaxel in treating women with stage IIIB-IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the dose of suramin in combination with paclitaxel (TXT) that results in suramin plasma concentrations approaching 10-50 uM over the duration, when TXT in the plasma is at therapeutically significant levels, in women with stage IIIB or IV breast cancer. (Phase I) II. Determine the objective response rate in patients treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

  1. Determine the pharmacokinetics of low-dose suramin in these patients. (Phase I) II. Determine the time to tumor progression in patients treated with this regimen. (Phase II) III. Determine the 1-year survival of patients treated with this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of suramin followed by a phase II multicenter study.

PHASE I: Patients receive low-dose suramin intravenously (IV) over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.

PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for the phase I study within 9 months. A total of 28 patients will be accrued for the phase II study within 18-24 months.

Being tested
suramin, paclitaxel, pharmacological study
Medical subject headings
Breast Neoplasms

What participants receive

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

  • suraminDrug

    Also called 309 F, Antrypol, Bayer 205, Fourneau 309

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00054028
Study groupRoleWhat they receive
Treatment (suramin and paclitaxel)ExperimentalPHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic. PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above.
Receives: Drug: suramin; Drug: paclitaxel; Other: pharmacological study

What is being measured

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

  1. Percentage of Patients That Achieved Target Suramin Concentrations in Plasma

    Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.

    Measured: Up to 5 years

  2. Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)

    Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) for target lesion s and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.

    Measured: Up to 8 weeks

Secondary outcomes (1)

  1. Response as Measured by RECIST Criteria

    Evaluation of secondary endpoints will be primarily descriptive. Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Response rates will include 95% confidence limits.

    Measured: Up to 5 years

Timeline

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

  1. First posted6 Feb 2003 (estimated)
  2. Study startDec 2002
  3. Primary completionMar 2008
  4. Study completionMar 2008

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054028
Sponsor's protocol ID
NCI-2012-01431
Other IDs
0216, OSU-02H0216, OSU-0216, NCI-5851, CDR0000269707, U01CA076576
Status last verified
Feb 2015
First submitted
5 Feb 2003
Last updated
17 Mar 2015

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing suramin, paclitaxel and pharmacological study in people with Recurrent Breast Cancer and Stage IIIB Breast Cancer, run by National Cancer Institute (NCI) 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?

The sponsor lists 40 inclusion and 0 exclusion criteria. 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 17 Mar 2015. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients That Achieved Target Suramin Concentrations in Plasma (time frame: Up to 5 years). The study lists 2 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 NCT00054028.

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 17 Mar 2015.

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