BMS-188797 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Treatment
|ClinicalTrials.gov Identifier: NCT00005611|
Recruitment Status : Unknown
Verified August 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 26, 2004
Last Update Posted : July 24, 2008
|First Submitted Date ICMJE||May 2, 2000|
|First Posted Date ICMJE||July 26, 2004|
|Last Update Posted Date||July 24, 2008|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005611 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||BMS-188797 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Treatment|
|Official Title ICMJE||Phase I Study of BMS-188797 in Patients With Advanced Malignancies|
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-188797 in treating patients who have advanced solid tumors that have not responded to previous treatment.
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose, dose limiting toxicities, and safety of BMS-188787 in patients with nonhematologic malignancies. II. Determine the plasma pharmacokinetics of BMS-188797 in these patients. III. Describe any antitumor activity of this treatment in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-188797 IV over 1 hour. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-188797 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 toxicities. Patients are followed every 4 weeks until toxicities resolve, and then at the investigator's discretion.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study over 12-18 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Unspecified Adult Solid Tumor, Protocol Specific|
|Intervention ICMJE||Drug: BMS-188797|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed nonhematologic malignancy unresponsive to existing therapy or for which no curative therapy exists Patients with prostate cancer must have withdrawn from antiandrogen therapy (flutamide, bicalutamide) for at least 4 weeks and must have progressive disease Measurable or evaluable disease No active brain metastases (e.g., cerebral edema, progression from prior imaging study, requirement for steroids, or clinical symptoms)
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) (unless due to hepatic metastases) Renal: Creatinine less than 1.5 times ULN Other: No serious uncontrolled medical disorder or active infection that would preclude study No hypersensitivity to agents containing polyoxyethylated castor oil (Cremophor EL) except in patients who received prior taxane therapy with premedication and did not experience greater than grade 1 hypersensitivity reaction 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: At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas, mitomycin, or carboplatin) Prior taxanes allowed No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since prior hormonal therapy No concurrent steroids No concurrent hormonal therapy (except leuprolide acetate for prostate cancer) Radiotherapy: At least 4 weeks since prior radiotherapy to 30% or more of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational anticancer therapy
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00005611|
|Other Study ID Numbers ICMJE||CDR0000067740
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||H. Lee Moffitt Cancer Center and Research Institute|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||August 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP