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CompletedNCT00551005Updated Nov 22, 2012

Etoposide and Celecoxib in Patients With Advanced Cancer

A Phase 1 interventional study of celecoxib and etoposide in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by City of Hope Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-22.

Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
58
Ages
18 Years and older
Sex
All
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Study summary

RATIONALE: Etoposide and celecoxib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than 1 drug may be an effective treatment for advanced cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with etoposide in treating patients with advanced cancer.

Read the detailed description

OBJECTIVES:

  • To describe the toxicities of the combination of oral etoposide at 50 mg daily with escalating doses of celecoxib in patients with advanced malignancies.
  • To evaluate the effects of the combination of etoposide and celecoxib on plasma levels of vascular endothelial growth factor.

OUTLINE: This is a dose-escalation study of celecoxib.

In course 1, patients receive oral etoposide once daily on days 1-35 and oral celecoxib twice daily on days 8-35. In all subsequent courses, patients receive oral etoposide once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, periodically during treatment, and at time of tumor progression. Samples are analyzed for vascular endothelial growth factor levels by enzyme-linked immunosorbent assay and stored for future analysis of circulating DNA of angiogenic biomarkers by polymerase chain reaction assays.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven diagnosis of a malignant disease for which no satisfactory treatment exists at the time of enrollment
  • Patients with brain metastases which at the time of study enrollment are controlled and do not require treatment with corticosteroids are eligible

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC > 1.5 x 10\^9/L
  • Platelet count > 100 x 10\^9/L
  • Creatinine clearance > 50 mL/min
  • Serum bilirubin \< 1.5 mg/dL
  • AST and ALT \< 2.0 times upper limit of normal (unless clearly due to the presence of tumor)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patient must be capable of understanding the nature of the trial and must give written informed consent

Exclusion criteria:

  • Unstable or severe intercurrent medical conditions or active, uncontrolled infection
  • History of allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs)
  • History of bleeding peptic ulcer within the past 3 months

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • Recovered from all prior chemotherapy or radiotherapy
  • Concurrent aspirin for cardiovascular indications allowed
  • More than 2 weeks since prior and no other concurrent NSAIDs

Exclusion criteria:

  • Had radiotherapy or chemotherapy within 3 weeks (nitrosoureas or mitomycin C within 6 weeks) prior to anticipated first day of dosing
  • Undergoing concurrent therapy with other investigational agents or antineoplastic therapy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
58 participants (actual)

Interventions

  • Drugcelecoxib
  • Drugetoposide
  • Otherimmunoenzyme technique
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Toxicity

  2. Maximum tolerated dose

  3. Survival

  4. Time to failure

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00551005
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 30, 2007
Start date
Dec 2001
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Nov 22, 2012

Study contacts

Przemyslaw W. Twardowski, MD
study chair · City of Hope Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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