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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006242 |
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.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: BMS-214662 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Farnesyltransferase Inhibitor BMS-214662 (NSC 710086) Escalating to a 24 Hour Continuous Intravenous Infusion in Patients With Solid Tumors |
Study Start Date: | November 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | Joseph Paul Eder, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000068170, DFCI-00003, NCI-67 |
Study First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006242 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |