LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Eli Lilly and Company; National Cancer Institute (NCI)
• Treatments: Capecitabine

Criteria

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