NCT00083109 is a Phase 1/Phase 2 clinical trial of Fluorouracil in Recurrent Renal Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT00083109?

NCT00083109 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00083109?

Interventions in NCT00083109: Fluorouracil, Pharmacological Study, Suramin.

What condition does NCT00083109 study?

NCT00083109 studies Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer.

Is NCT00083109 still recruiting?

NCT00083109 is currently completed. Last updated 22 May 2015.

Last reviewed 2015-05-22 · How we verify

NCT00083109

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1/Phase 2 Last updated 22 May 2015

What this trial tests

Phase 1/Phase 2 trial testing Fluorouracil in Recurrent Renal Cell Carcinoma in 36 participants. Completed in 1 March 2008.

Timeline

1 March 2004

Primary endpoint
1 December 2005

1 March 2008

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 March 2004
Primary completion	1 December 2005
Estimated completion	1 March 2008
Sites	1 location across United States

Drugs / interventions tested

Fluorouracil — full drug profile →
Pharmacological Study — full drug profile →
Suramin — full drug profile →

Conditions studied

Recurrent Renal Cell Carcinoma — all drugs for Recurrent Renal Cell Carcinoma →
Stage IV Renal Cell Cancer — all drugs for Stage IV Renal Cell Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Recurrent Renal Cell Carcinoma or Stage IV Renal Cell Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Dose of suramin to deliver the target plasma concentrations of 10 to 50 uM (Phase I)
Time frame: Up to 48 hours
Objective response rate (CR + PR) using RECIST criteria (Phase II)
Time frame: Up to 4 years
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.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
100 Years of Suramin.
Wiedemar N, Hauser DA, Mäser P. · · 2020 · cited 135× · PMID 31844000 · DOI 10.1128/aac.01168-19
Targeting Frequent Efferocytosis in Tumor Microenvironment is a New Direction for Cancer Treatment.
Zhu G, Wan X, Wu W, Jia L, et al · · 2025 · cited 3× · PMID 40657202 · DOI 10.1002/smsc.202400479
Metabolic reprogramming of efferocytosis in the tumour microenvironment: From apoptotic-cell clearance to therapeutic targeting.
Yang Q, Yan J, Yang Q. · · 2026 · cited 1× · PMID 41601343 · DOI 10.1002/ctm2.70601

Verify or expand the search:

Other trials of Fluorouracil

Trials testing the same drug.

NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
NCT07271355 — Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colore · Phase 3 · not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07456852 — Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Ca · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Recurrent Renal Cell Carcinoma

Currently open trials in the same condition.

NCT05641935 — Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation · Phase 2 · recruiting
NCT04514484 — Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and · Phase 1 · active not recruiting
NCT03092856 — Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer · Phase 2 · active not recruiting
NCT02867592 — Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, · Phase 2 · active not recruiting
NCT02664883 — Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer · active not recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00083109 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 22 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00083109.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing