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LY293111 in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00006375
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : June 18, 2013
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: LY293111 Phase 1

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: 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
Primary Completion Date : February 2003
Study Completion Date : February 2003
Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006375


Locations
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center
More Information

ClinicalTrials.gov Identifier: NCT00006375     History of Changes
Other Study ID Numbers: 00-076
CDR0000068249 ( Registry Identifier: PDQ (Physician Data Query) )
MSKCC-H6H-MC-JEAI
NCI-G00-1862
First Posted: February 12, 2004    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific