NCT00003705

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of BMS-184476 in treating patients who have advanced solid tumors.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

2 active sites

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

November 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

March 15, 2004

Completed
Last Updated

July 24, 2008

Status Verified

August 1, 2007

First QC Date

November 1, 1999

Last Update Submit

July 23, 2008

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

BMS-184476DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumors refractory to conventional anticancer therapy, or for which no effective therapy exists Measurable or evaluable disease No active 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 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No uncontrolled or significant cardiovascular disease No myocardial infarction within past 6 months No congestive heart failure (with or without therapy) No history of atrial or ventricular arrhythmias No history of second or third degree heart block Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious uncontrolled medical disorder or active infection No known hypersensitivity to drugs containing Cremophor EL No concurrent neurologic toxicity No dementia or altered mental status PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas, mitomycin, or carboplatin) Prior taxane therapy allowed No other concurrent chemotherapy Endocrine therapy: At least 1 week since prior steroid therapy No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior wide field radiotherapy (involving at least 30% of the bone marrow) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental anticancer medications

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

Sponsors & Collaborators

Study Sites (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

San Antonio Cancer Institute

San Antonio, Texas, 78229-3264, United States

Location

Related Publications (2)

  • Plummer R, Ghielmini M, Calvert P, Voi M, Renard J, Gallant G, Gupta E, Calvert H, Sessa C. Phase I and pharmacokinetic study of the new taxane analog BMS-184476 given weekly in patients with advanced malignancies. Clin Cancer Res. 2002 Sep;8(9):2788-97.

    PMID: 12231518BACKGROUND

  • Hidalgo M, Aylesworth C, Hammond LA, Britten CD, Weiss G, Stephenson J Jr, Schwartz G, Patnaik A, Smith L, Molpus K, Felton S, Gupta E, Ferrante KJ, Tortora A, Sonnichsen DS, Skillings J, Rowinsky EK. Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. J Clin Oncol. 2001 May 1;19(9):2493-503. doi: 10.1200/JCO.2001.19.9.2493.

    PMID: 11331328RESULT

MeSH Terms

Interventions

7-methylthiomethylpaclitaxel

Study Officials

  • Manuel Hidalgo, MD, PhD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 15, 2004

Study Start

November 1, 1997

Last Updated

July 24, 2008

Record last verified: 2007-08

Locations

US(2)