LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function.

PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function.

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

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Lily Research Laboratories; National Cancer Institute (NCI)
• Treatments: Pemetrexed

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or locally advanced solid tumors that have failed standard therapy or for which no standard therapy exists Measurable or evaluable disease No active, symptomatic brain metastases No leukemia, lymphoma, or multiple myeloma No significant pleural or peritoneal effusions

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 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if due to liver disease) Albumin at least 2.0 g/dL Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No active infection or serious concurrent systemic disorders No second primary malignancy in the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin No body surface area greater than 3 m2

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except contraceptives and corticosteroids) Radiotherapy: At least 4 weeks since prior radiotherapy (including wide field pelvic radiation) No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational agents Concurrent warfarin and heparin allowed No aspirin and other nonsteroidal antiinflammatory 2 days before, the day of, and 2 days after LY231514 administration (5 days for long-acting agents) No concurrent nonsteroidal antiinflammatory drugs or salicylates with a long half-life e.g., naproxen, piroxicam, diflunisal, or nabumetone) No other concurrent experimental medications No concurrent dialysis