NCT00083109

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 25, 2015

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

May 14, 2004

Last Update Submit

May 22, 2015

Conditions

Recurrent Renal Cell CarcinomaStage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (2)

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

    Up to 48 hours

  • Objective response rate (CR + PR) using RECIST criteria (Phase II)

    Summary statistics (e.g. means and standard deviations or medians and ranges, or frequency counts) and 95% confidence intervals will be calculated. Graphical models will also be used to summarize the data.

    Up to 4 years

Secondary Outcomes (4)

  • Progression rate (Phase II)

    3 months

  • Progression rate (Phase II)

    6 months

  • Time to disease progression (Phase II)

    Up to 4 years

  • Toxicity assessed using NCI CTCAE version 3.0 (Phase II)

    Up to 4 years

Study Arms (1)

Treatment (suramin and fluorouracil)

EXPERIMENTAL

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.

Drug: FluorouracilOther: Pharmacological StudyDrug: Suramin

Interventions

FluorouracilDRUG

Given IV

Also known as: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Actino-Hermal, Adrucil, Arumel, Cytosafe, Efudex, Efurix, Fiverocil, Fluoro Uracil, Fluoroplex, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Flurox, Ribofluor, Ro 2-9757, Ro-2-9757, Timazin
Treatment (suramin and fluorouracil)
Pharmacological StudyOTHER

Correlative studies

Treatment (suramin and fluorouracil)
SuraminDRUG

Given IV

Treatment (suramin and fluorouracil)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

FluorouracildehydroftorafurSuramin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic Compounds

Study Officials

  • Ronald Bukowski

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 17, 2004

Study Start

March 1, 2004

Primary Completion

December 1, 2005

Study Completion

March 1, 2008

Last Updated

May 25, 2015

Record last verified: 2013-01

Locations

US(1)