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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006375 |
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 LY293111 in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: LY293111 |
Phase I |
MedlinePlus related topics: | Cancer |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Clinical and Pharmacokinetic Evaluation of LY293111 in Patients With Solid Tumors (Protocol H6H-MC-JEAI) |
Study Start Date: | June 2000 |
OBJECTIVES: I. Determine the maximum tolerated dose of LY293111 in patients with advanced solid tumors. II. Determine the safety profile and pharmacokinetics of this regimen in these patients. III. Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral LY293111 twice daily. Treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LY293111 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicity. Additional patients are treated at the MTD. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced and/or metastatic solid tumor for which no curative therapy exists No hematologic malignancies Measurable or evaluable disease No known CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.0 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No concurrent systemic disorder that would preclude study No active infection
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy Chemotherapy: No more than 3 prior chemotherapy regimens for metastatic disease At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior anticancer hormonal therapy and recovered No concurrent anticancer hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational therapy No other concurrent experimental medications
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 | |||||
North Shore University Hospital | |||||
Manhasset, New York, United States, 11030 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068249, MSKCC-00076, MSKCC-H6H-MC-JEAI, NCI-G00-1862 |
First Received: | October 4, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006375 |
Health Authority: | United States: Federal Government |
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