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Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)

Phase 1/Phase 2
18 Years
Not Enrolling
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)


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)


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose of suramin to deliver the target plasma concentrations of 10 to 50 uM (Phase I)

Outcome Time Frame:

Up to 48 hours

Safety Issue:


Principal Investigator

Ronald Bukowski

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell



Cleveland Clinic Foundation Cleveland, Ohio  44195