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CompletedNCT00551889Updated Nov 12, 2012

Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer

A Phase 1 interventional study of celecoxib and cyclophosphamide 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 2012-11-12.

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

Phase
Phase 1
Study type
Interventional
Enrollment
57
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may help kill more cancer cells.

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

Read the detailed description

OBJECTIVES:

  • To describe the toxicities of oral cyclophosphamide when administered with escalating doses of celecoxib in patients with advanced malignancies.
  • To evaluate the effects of this regimen on plasma levels of vascular endothelial growth factor.

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

In the first course, patients receive oral cyclophosphamide once daily on days 1-35 and oral celecoxib twice daily on days 8-35. In all subsequent courses, patients receive oral cyclophosphamide 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 and stored for future analysis of circulating DNA of angiogenic biomarkers.

After completion of study therapy, patients are followed periodically.

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 that, at the time of study enrollment, are controlled and do not require treatment with corticosteroids are eligible

PATIENT CHARACTERISTICS:

  • 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 or ALT \< 2.0 times upper limit of normal (unless clearly due to the presence of tumor)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Patient must be capable of understanding the nature of the trial and must give written informed consent
  • No unstable or severe intercurrent medical conditions or active, uncontrolled infection
  • No history of allergic reactions to nonsteroidal anti-inflammatory drugs
  • No bleeding peptic ulcer within the past 3 months
  • No allergy to sulfa drugs

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy
  • No radiotherapy or chemotherapy within the 3 weeks (nitrosoureas or mitomycin C within 6 weeks) prior to anticipated first day of dosing
  • No concurrent therapy with other investigational agents or antineoplastic therapy
05

Study design

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

Interventions

  • Drugcelecoxib
  • Drugcyclophosphamide
  • 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 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00551889
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 31, 2007
Start date
Sep 2001
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Nov 12, 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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