LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors

Inclusion Criteria:

• Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
• Measurable or evaluable disease
• 18 and over
• ECOG 0-2

• Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (erythrocyte transfusions allowed)

• Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)

• Renal

  • Creatinine clearance at least 50 mL/min
  • Potassium at least 3.4 mEq/L
  • Calcium at least 8.4 mg/dL
  • Magnesium at least 1.2 mEq/L

• Cardiovascular

  • QTc interval no greater than 450 msec in males
  • QTc interval no greater than 470 msec in females
  • No other electrocardiogram abnormalities
• Able to swallow capsules
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3-6 months after study

• Endocrine therapy

  • At least 4 weeks since prior anticancer hormonal therapy
  • At least 6 weeks since prior bicalutamide
  • At least 4 weeks since prior flutamide or nilutamide
  • Concurrent luteinizing hormone-releasing hormone analog therapy (e.g., leuprolide or goserelin) allowed for patients with prostate cancer if started before study entry
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin).

• Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • At least 2 weeks since prior palliative radiotherapy
  • Recovered from prior therapy

• Other

  • At least 4 weeks since prior investigational anticancer therapy
  • At least 4 weeks since other prior anticancer therapy
  • At least 30 days since prior experimental drugs

Exclusion Criteria:

• known untreated or symptomatic CNS metastases
• concurrent hematologic malignancies
• gastrointestinal disorder that would interfere with oral drug absorption
• serious concurrent systemic disorder
• compliance issues that would preclude study
• geographical conditions that would preclude study
• active infection
• prior hypersensitivity to any component of study drugs
• pregnant or nursing
• concurrent immunotherapy
• concurrent routine filgrastim (G-CSF)
• other concurrent chemotherapy
• other concurrent hormonal therapy
• concurrent radiotherapy (including palliative therapy)
• other concurrent experimental medications
• other concurrent anticancer therapy