Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00551889
Recruitment Status : Completed
First Posted : October 31, 2007
Last Update Posted : November 12, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

October 30, 2007
October 31, 2007
November 12, 2012
September 2001
February 2012   (Final data collection date for primary outcome measure)
  • Toxicity
  • Maximum tolerated dose
  • Survival
  • Time to failure
Same as current
Complete list of historical versions of study NCT00551889 on Archive Site
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Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer
Phase I Trial of Oral Cyclophosphamide in Combination With Celecoxib in Patients With Advanced Malignancies

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: celecoxib
  • Drug: cyclophosphamide
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2012
February 2012   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000570416 ( Registry Identifier: NCI PDQ )
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City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Study Chair: Przemyslaw W. Twardowski, MD City of Hope Comprehensive Cancer Center
City of Hope Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP