Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. This phase I/II trial is studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and to see how well they work in treating patients with metastatic renal cell (kidney) cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorouracil; Suramin

Criteria

Inclusion Criteria:

• Histologically confirmed renal cell cancer

• Metastatic disease

• Measurable or evaluable disease

• Measurable disease required for phase II

• No untreated CNS metastasis or CNS metastases progressing ≤ 4 weeks after prior radiotherapy

• Performance status - ECOG 0-1

• At least 12 weeks

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

• AST ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 5 times ULN

• Bilirubin ≤ 1.5 mg/dL

• Creatinine ≤ 1.8 mg/dL

• Calcium ≤ ULN

• No untreated hypercalcemia

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must be surgically sterile or use effective contraception

• No uncontrolled diabetes mellitus

• No known severe hypersensitivity to suramin

• No other concurrent uncontrolled illness

• No active or ongoing infection

• No active autoimmune disease

• No neuropathy ≥ grade 2

• No psychiatric illness or social situation that would preclude study compliance

• No other malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or localized prostate cancer

• No concurrent filgrastim (G-CSF)

• No more than 2 prior chemotherapy regimens for renal cell cancer (phase II only)

• No concurrent corticosteroid dose more than physiologic replacement levels

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

• Recovered from prior oncologic or other major surgery

• At least 4 weeks since prior major surgery

• No concurrent surgery

• Recovered from all prior anticancer therapy other than alopecia (chronic toxicity < grade 2)

• At least 4 weeks since prior systemic therapy

• More than 30 days since prior investigational drugs

• Concurrent bisphosphonates allowed