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

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