Trial · NCT00357500

Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer

NCT00357500, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2014-09-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer. Trials, record NCT00357500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00357500

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Trial

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

Title: Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer
NCT number: NCT00357500
Status: Completed
Phases: Phase 2
Enrollment: 101 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Central Nervous System Tumor, Pediatric, Leukemia, Lymphoma, Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Interventions: celecoxib, cyclophosphamide, etoposide, fenofibrate, thalidomide
First posted: 2006-07-27
Last updated: 2014-10-01
Results first posted: 2014-09-09

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Therapy Completion Rate	27 weeks	Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as \>/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as \>/=25% or \>/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Secondary	27-Week Progression-Free Survival	Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.	27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as \>/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as \>/=25% or \>/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Secondary	27-Week Overall Survival	Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.	27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods.
Secondary	Best Response	Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.	As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); \>/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); \<50% decrease and \<25% increase in product of diameters, stable disease (SD); and \>/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as \>/=25% or \>/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Therapy Completion Rate	27 weeks	The analysis dataset is comprised of all treated patients.	proportion of patients	NUMBER
SECONDARY	27-Week Progression-Free Survival	Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.	The analysis dataset is comprised of all treated patients.	Probability	NUMBER
SECONDARY	27-Week Overall Survival	Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.	The analysis dataset is comprised of all treated patients.	Probability	NUMBER
SECONDARY	Best Response	Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.		participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Therapy Completion Rate	5-drug Metronomic Antiangiogenic Regimen		.25	90% Confidence Interval .18 to .33	proportion of patients
27-Week Progression-Free Survival	5-drug Metronomic Antiangiogenic Regimen		0.31	95% Confidence Interval 0.21 to 0.42	Probability
27-Week Overall Survival	5-drug Metronomic Antiangiogenic Regimen		0.61	95% Confidence Interval 0.49 to 0.71	Probability
Best Response	5-drug Metronomic Antiangiogenic Regimen	Complete Response	1		participants
Best Response	5-drug Metronomic Antiangiogenic Regimen	Partial Response	12		participants
Best Response	5-drug Metronomic Antiangiogenic Regimen	Stable Disease	36		participants
Best Response	5-drug Metronomic Antiangiogenic Regimen	Progressive Disease	47		participants
Best Response	5-drug Metronomic Antiangiogenic Regimen	Not Evaluable	1		participants

Source ClinicalTrials.gov

Participant flow4

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

Period	Milestone	Group	Participants
Overall Study	STARTED	5-drug Metronomic Antiangiogenic Regimen	101
Overall Study	Began Protocol Therapy	5-drug Metronomic Antiangiogenic Regimen	97
Overall Study	COMPLETED	5-drug Metronomic Antiangiogenic Regimen	24
Overall Study	NOT COMPLETED	5-drug Metronomic Antiangiogenic Regimen	77

Source ClinicalTrials.gov

Adverse events180

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

Type	Event	Organ system	Group	Affected	At risk
other	Myelodysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Hemoglobin	Blood and lymphatic system disorders	5-drug Metronomic Antiangiogenic Regimen	52	97
other	Palpitations	Cardiac disorders	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Sinus tachycardia	Cardiac disorders	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Cushingnoid appearance	Endocrine disorders	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Neuropathy CN II vision	Eye disorders	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Cataract	Eye disorders	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Keratitis	Eye disorders	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Ocular-other	Eye disorders	5-drug Metronomic Antiangiogenic Regimen	1	97
other	Constipation	Gastrointestinal disorders	5-drug Metronomic Antiangiogenic Regimen	16	97

1 to 10 of 180Source ClinicalTrials.gov

See all 180 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	5-drug Metronomic Antiangiogenic Regimen
Total, other adverse events	5-drug Metronomic Antiangiogenic Regimen	81	97
Total, serious adverse events	5-drug Metronomic Antiangiogenic Regimen	74	97

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24123865	BACKGROUND

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA006516	Dana-Farber/Harvard Cancer Center	EBERT, BENJAMIN LEVINE	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

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/NCT00357500

GET https://conductscience.org/api/trials/v1/NCT00357500/events?page=2

API reference For AI assistants