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Trial · NCT00176280

Randomized Phase 2 Trial of Pre-chemotherapy Leukine vs. Leukine-Dexamethasone in Combination With Gemzar & 5-FU in Patients With Metastatic Renal Cell Carcinoma

NCT00176280, Phase 2, Withdrawn, University of Kentucky

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Randomized Phase 2 Trial of Pre-chemotherapy Leukine vs. Leukine-Dexamethasone in Combination With Gemzar & 5-FU in Patients With Metastatic Renal Cell Carcinoma. Trials, record NCT00176280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00176280

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Randomized Phase 2 Trial of Pre-chemotherapy Leukine vs. Leukine-Dexamethasone in Combination With Gemzar & 5-FU in Patients With Metastatic Renal Cell Carcinoma
NCT number
NCT00176280
Status
Withdrawn
Phases
Phase 2
Enrollment
0 participants, actual
Lead sponsor
University of Kentucky
Conditions
Renal Cell Carcinoma
Interventions
Leukine, Dexamethasone
First posted
2005-09-15
Last updated
2015-06-18

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary% of subjects with CR or PR evaluated after course 2 then every other course using RECIST for both cohorts
PrimarySurvival (assessed until death)
PrimaryQOL (evaluated after courses 3 & 5 then every other course)
Primary% of subjects with >/= grade 3 hematopoietic & non-hematopoietic toxicities (assessed 3/week on treatment & continuing until counts recover)
Secondary
Days with <AGC 500 & platelet (PLC)< 20K mm3, # of febrile neutropenia hospital days, # of transfusions, bleeding & # of outpatient antibiotic days (assessed 3/week on treatment then until counts recover)
SecondaryLevels of peripheral blood dendritic cell # & function, plasma levels of cytokines including VEGF & TNF alpha (performed on days 1 & 7 of treatment)

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00176280

GET https://conductscience.org/api/trials/v1/NCT00176280/registered