Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)
Fluorouracil
+ Pharmacological Study
+ Suramin
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. Determine the dose of suramin and fluorouracil that would result in plasma concentrations of suramin between 10-50 uM in patients with metastatic renal cell cancer. (Phase I) II. Determine the objective response rate (complete response and partial response) in patients treated with this regimen. (Phase II) SECONDARY OBJECTIVES: I. Determine the preliminary efficacy of this regimen in these patients. (Phase I) II. Determine the pharmacokinetics of low-dose suramin in these patients. (Phase I) III. Determine the time to tumor progression and progress rate at 3 and 6 months in patients treated with this regimen. (Phase II) OUTLINE: This is a dose-escalation phase I study followed by a phase II study. PHASE I: Patients receive suramin IV over 30 minutes and fluorouracil IV on days 1, 8, 15, 22, 29, and 36. Cohorts of 3-6 patients receive escalating doses suramin and fluorouracil until the dose level allowing 10-50 uM of suramin into the patient's blood is determined without 2 or more of 6 patients experiencing dose-limiting toxicity. PHASE II: Patients receive suramin and fluorouracil (at the dose level determined in phase I) as in phase I. In both phases, courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location