NCT00022529

Brief Summary

Phase I trial to study the effectiveness of BMS-214662 plus trastuzumab in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

June 17, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

August 10, 2001

Last Update Submit

January 24, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the highest dose level at which =< 1/6 subjects experience a study related dose-limiting toxicity (DLT) as assessed by CTC version 2.0

    28 days

Study Arms (1)

Treatment (BMS-214662, trastuzumab)

EXPERIMENTAL

Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: BMS-214662Biological: trastuzumabOther: pharmacological study

Interventions

BMS-214662DRUG

Given IV

Also known as: farnesyltransferase inhibitor BMS-214662, FTI BMS 214662
Treatment (BMS-214662, trastuzumab)
trastuzumabBIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2
Treatment (BMS-214662, trastuzumab)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (BMS-214662, trastuzumab)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists
  • Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization
  • Clinically or radiologically evaluable disease
  • No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease
  • At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.8 mg/dL
  • ALT and AST no greater than 1.5 times upper limit of normal (ULN)
  • Creatinine no greater than 1.5 times ULN
  • No uncontrolled or significant cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No prior clinically significant atrial or ventricular arrhythmias
  • No prior second or third degree heart block
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Interventions

7-cyano-2,3,4,5-tetrahydro-1-(1H-imidazol-4-ylmethyl)-3-(phenylmethyl)-4-(2-thienylsulfonyl)-1H-1,4-benzodiazepineTrastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mary Cianfrocca

    Fox Chase Cancer Center

    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

August 10, 2001

First Posted

June 17, 2003

Study Start

July 1, 2001

Primary Completion

January 1, 2004

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)