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Phase I Study of BMS-214662 and Paclitaxel in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of BMS-214662 and Paclitaxel in Patients With Advanced Malignancies


OBJECTIVES: I. Determine the maximum tolerated dose of BMS-214662 in combination with
paclitaxel in patients with advanced solid tumors. II. Determine the safety and tolerability
of this regimen in these patients. III. Determine the pharmacokinetics of this treatment
regimen in this patient population. IV. Determine the pharmacodynamic effects of this
treatment regimen in serial tumor biopsies in these patients. V. Determine the cytotoxicity
of this treatment regimen in these patients.

OUTLINE: This is a dose-escalation study of BMS-214662. Patients receive paclitaxel IV over
3 hours on day 1 and BMS-214662 IV over 1 hour on day 3 of course 1. For all subsequent
courses, patients receive paclitaxel IV over 3 hours followed 30 minutes later by BMS-214662
IV over 1 hour on day 1. Treatment repeats every 3 weeks for at least 2 courses in the
absence of disease progression or unacceptable toxicity. Patients with stable disease or
objectively responding disease receive additional therapy at the investigator's discretion.
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A maximum of 18-21 patients will be accrued for this study within 12-15
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor
unresponsive to standard therapy or for which no effective therapy exists Measurable or
evaluable disease amenable to CT-guided or percutaneous needle biopsy No active
symptomatic brain metastases requiring steroids, including evidence of cerebral edema on
CT scan or MRI or progression from prior imaging study

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/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT/AST no greater than
2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN
Cardiovascular: No history of clinically significant cardiac arrhythmia that could be
exacerbated by QT interval prolongation No uncontrolled or significant cardiovascular
disease No myocardial infarction within the past 6 months No significant congestive heart
failure No second- or third- degree heart block No prolonged QTc interval (greater than
450 ms) on EKG Pulmonary: No uncontrolled or significant pulmonary disease Other: No
serious uncontrollable medical disorder or active infection that would preclude study No
dementia or altered mental status that would preclude study 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
Chemotherapy: No more than 2 prior chemotherapy regimens Prior taxanes allowed At least 4
weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) No other concurrent
chemotherapy Endocrine therapy: See Disease Characteristics No concurrent antineoplastic
hormonal therapy Concurrent hormone replacement therapy allowed Radiotherapy: At least 4
weeks since prior wide-field radiotherapy No concurrent radiotherapy Surgery: Not
specified Other: At least 4 weeks since prior investigational drugs At least 7 days since
prior substrates of cytochrome P450-3A4 (CYP3A4) No other concurrent experimental
anticancer medications No concurrent dolasetron or droperidol No medications or other
agents known to prolong the QT interval for at least 4 half-lives prior to, during, and
for 24 hours after administration of BMS-214662 Concurrent antihistamines allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel.

Outcome Time Frame:

Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Safety Issue:

Yes

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU4Y99

NCT ID:

NCT00006018

Start Date:

July 2000

Completion Date:

April 2002

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Ireland Cancer Center at University Hospitals Case Medical CenterCleveland, Ohio  44106-5065