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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00028561

BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors

A Phase 1 study testing ixabepilone, carboplatin and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of BMS-247550 when given together with carboplatin in treating patients with recurrent or refractory solid tumors. 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
What is being tested?
ixabepilone, carboplatin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Oct 2001to Feb 2007
Phase
Phase 1
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

Who may be able to join

  • Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
  • Measurable or evaluable disease
  • Lesion accessible for core or excisional biopsy if being treated at the maximum tolerated dose (MTD)
  • No biliary tract dilation if radiologically guided biopsy of the liver is planned
  • No requirement for core biopsy of lung lesion that is not pleural based
  • No requirement for laparotomy or thoracotomy solely for biopsy
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  • No medical condition that would preclude biopsy
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - ECOG 0-1 if being treated at the MTD
  • More than 3 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No prior bleeding disorder or unexplained bleeding if being treated at the MTD
  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • PT/PTT normal
  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 60 mL/min
  • 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 other concurrent uncontrolled illness that would preclude study participation
  • No ongoing or active infection
  • No grade 2 or greater neuropathy (sensory or motor)
  • No prior severe allergic reaction attributable to compounds containing Cremophor EL or platinum agents
  • No psychiatric illness or social situation that would preclude study compliance
  • No medical condition that would preclude study if being treated at the MTD
  • At least 4 week since prior immunotherapy
  • At least 24 hours since prior growth factors
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No more than 3 prior chemotherapy regimens
  • No prior epothilone agents
  • At least 1 week since prior hormonal therapy directed at malignancy
  • Concurrent hormone replacement therapy allowed
  • At least 4 weeks since prior wide-field radiotherapy involving 30% or more of bone marrow
  • See Disease Characteristics
  • At least 4 weeks since prior investigational agents
  • No prior or concurrent St. John's Wort
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No concurrent heparin or other anticoagulants if being treated at the MTD
  • No concurrent inhibitors of cytochrome P450 3AP (CYP3A4)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I Study of Epothilone B Analog BMS 247550 in Combination With Carboplatin in Recurrent and/or Refractory Solid Tumors

This phase I trial is studying the side effects and best dose of BMS-247550 when given together with carboplatin in treating patients with recurrent or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose of BMS-247550 when given in combination with carboplatin in patients with recurrent or refractory solid tumors.

II. Determine the dose-limiting toxicity and safety of this regimen in these patients.

III. Determine the plasma pharmacokinetics of this regimen in these patients. IV. Determine, preliminarily, any antitumor activity of this regimen in these patients.

  1. Correlate the protein expression of survivin with the expression of other apoptotic regulators, the apoptotic index, and response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of BMS-247550.

Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15 followed by carboplatin IV over 1 hour on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR or up to a total of 6 courses. The first two cohorts of 3-6 patients each receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).The third and fourth cohorts of 10 patients each receive escalating doses of BMS-247550 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 10 patients experience DLT. Once the MTD is determined for the third and fourth cohorts, 15 additional patients are treated at the MTD. Patients are followed for 30 days.

Being tested
ixabepilone, carboplatin, laboratory biomarker analysis, pharmacological study

What participants receive

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

  • ixabepiloneDrug

    Also called BMS-247550, epothilone B lactam, Ixempra

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00028561
Study groupRoleWhat they receive
Treatment (ixabepilone, carboplatin)ExperimentalPatients receive BMS-247550 IV over 1 hour on days 1, 8, and 15 followed by carboplatin IV over 1 hour on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a CR receive 2 additional courses after achieving CR or up to a total of 6 courses
Receives: Drug: ixabepilone; Drug: carboplatin; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

  1. MTD of ixabepilone defined as the first dosage tier below the MAD in which =< 1/6 patients experiences a DLT

    Measured: 28 days

Secondary outcomes (1)

  1. Pharmacokinetics of ixabepilone and carboplatin

    Measured: Week 1

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001
  3. Primary completionFeb 2007

Why it stopped: Administratively complete.

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028561
Sponsor's protocol ID
NCI-2012-02726
Other IDs
12657, CDR0000069105
Status last verified
Jan 2013
First submitted
4 Jan 2002
Last updated
17 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ixabepilone, carboplatin and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, 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 46 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: stopped early, as of the sponsor's last update on 17 Jan 2013. 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 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.

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 was stopped early (reason given: Administratively complete.). Results are not available in the source record.

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?

MTD of ixabepilone defined as the first dosage tier below the MAD in which =< 1/6 patients experiences a DLT (time frame: 28 days). 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 NCT00028561.

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 Jan 2013.

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