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BMS-214662 in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00006242   Information provided by National Cancer Institute (NCI)
First Received: September 11, 2000   Last Updated: July 23, 2008   History of Changes

September 11, 2000
July 23, 2008
November 2000
 
 
 
Complete list of historical versions of study NCT00006242 on ClinicalTrials.gov Archive Site
 
 
 
BMS-214662 in Treating Patients With Advanced Solid Tumors
A Phase I Trial of Farnesyltransferase Inhibitor BMS-214662 (NSC 710086) Escalating to a 24 Hour Continuous Intravenous Infusion in Patients With Solid Tumors

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-214662 in treating patients who have advanced solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of BMS-214662 in patients with advanced solid tumors.
  • Determine the safety of an appropriate dose of this drug for phase II studies.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the extent and duration of farnesyltransferase inhibition in peripheral blood mononuclear cells and other relevant surrogate markers of pharmacological activity in patients treated with this drug.
  • Determine any preliminary evidence of antitumor activity of this drug in these patients.
  • Determine pharmacodynamic relationships for the pharmacological effect of this drug upon surrogate markers of activity and host toxicity in these patients.
  • Compare the toxicity profiles for the 1-hour vs 24-hour IV infusions of this drug in these patients.

OUTLINE: This is a dose-prolongation, dose-escalation study.

Single patient cohorts receive BMS-214662 IV over escalating periods of 2, 4, 8, 16, and 24 hours weekly for 3 weeks followed by 1 week of rest. If no patient experiences dose-limiting toxicity (DLT), dose escalation proceeds in the single patient cohorts.

Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Individual patient cohorts may increase their duration of BMS-214662 infusion in subsequent courses to the current duration safely reached.

Beginning with the infusion level at which DLT is first encountered by a single patient, 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 3 or 2 of 6 patients experience DLT. An additional cohort of 10 patients is treated at the MTD.

Patients are followed for at least 4 weeks.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: BMS-214662
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic or inoperable malignancy for which no known curative or survival-prolonging palliative therapy exists or which has failed these therapies
  • No leukemia or primary CNS tumor
  • No active brain metastases, including cerebral edema by CT scan or MRI, progression from prior imaging study, requirement for steroids, or clinical symptoms

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN)
  • Bilirubin no greater than ULN

Renal:

  • Creatinine no greater than ULN
  • Creatinine clearance at least 50 mL/min
  • No known pre-existing renal disease

Cardiovascular:

  • No clinically significant atrial or ventricular arrhythmias
  • No second- or third-degree heart block or prolonged QTc interval (greater than 450 ms)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled serious medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • At least 3 weeks since prior major surgery

Other:

  • At least 7 days since prior substrates of cytochrome P450-3A4 (CYP3A4), including terfenadine, astemizole, triazolam, midazolam, cisapride, bepridil, rifabutin, simvastatin, lovastatin, and propafenone
  • No substrates of CYP3A4 during and for at least 1 week after study
  • No non-steroidal anti-inflammatory drugs or other potentially nephrotoxic medications for at least 2 days before, during, and for at least 2 days after study drug administration
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006242
 
CDR0000068170, DFCI-00003, NCI-67
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Joseph Paul Eder, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP