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A Phase I Clinical and Pharmacokinetic Evaluation of LY293111 in Patients With Solid Tumors (Protocol H6H-MC-JEAI)


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Clinical and Pharmacokinetic Evaluation of LY293111 in Patients With Solid Tumors (Protocol H6H-MC-JEAI)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary K. Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-076

NCT ID:

NCT00006375

Start Date:

June 2000

Completion Date:

February 2003

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
North Shore University HospitalManhasset, New York  11030