NCT00028561

Brief 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. Combining more than one drug may kill more tumor cells

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

5.3 years

First QC Date

January 4, 2002

Last Update Submit

January 16, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

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

    28 days

Secondary Outcomes (1)

  • Pharmacokinetics of ixabepilone and carboplatin

    Week 1

Study Arms (1)

Treatment (ixabepilone, carboplatin)

EXPERIMENTAL

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 CR receive 2 additional courses after achieving CR or up to a total of 6 courses

Drug: ixabepiloneDrug: carboplatinOther: laboratory biomarker analysisOther: pharmacological study

Interventions

ixabepiloneDRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra
Treatment (ixabepilone, carboplatin)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Treatment (ixabepilone, carboplatin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (ixabepilone, carboplatin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (ixabepilone, carboplatin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Interventions

ixabepiloneCarboplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Daniel Sullivan

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

February 1, 2007

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)