NCT00006086

Brief Summary

RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2002

Enrollment Period

2.7 years

First QC Date

August 3, 2000

Last Update Submit

September 8, 2010

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

BMS-188797DRUG
carboplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced nonhematologic malignancy that has progressed on standard therapy or for which no curative therapy exists * No brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 2.5 times upper limit of normal (ULN) unless due to hepatic metastases Renal: * Creatinine no greater than 1.5 times ULN Other: * No chronic medical condition requiring treatment with corticosteroids * No prior severe hypersensitivity reaction to agents containing Cremophor (polyoxyethylated castor oil) * No serious uncontrolled medical disorder, active infection, or psychiatric disorder (e.g., dementia) that would preclude study * No preexisting neurotoxicity grade 1 or greater * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No more than 2 prior chemotherapy regimens for metastatic disease * No prior platinum or taxane therapy * No other concurrent chemotherapy Endocrine therapy: * At least 2 weeks since prior hormonal therapy (except megestrol for anorexia/cachexia) and recovered * At least 7 days since prior corticosteroids * No concurrent corticosteroids * No concurrent hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy to 30% or more of bone marrow and recovered * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent investigational drug

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Related Publications (1)

  • Fishman MN, Garrett CR, Simon GR, Chiappori AA, Lush RM, Dinwoodie WR, Mahany JJ, Dellaportas AM, Cantor A, Gollerki A, Cohen MB, Sullivan DM. Phase I study of the taxane BMS-188797 in combination with carboplatin administered every 3 weeks in patients with solid malignancies. Clin Cancer Res. 2006 Jan 15;12(2):523-8. doi: 10.1158/1078-0432.CCR-05-0928.

    PMID: 16428495RESULT

MeSH Terms

Interventions

BMS188797Carboplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Daniel M. Sullivan, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2000

First Posted

May 22, 2003

Study Start

June 1, 2000

Primary Completion

February 1, 2003

Last Updated

September 9, 2010

Record last verified: 2002-09

Locations

US(1)