Etoposide and Celecoxib in 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: NCT00551005
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : November 22, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: celecoxib Drug: etoposide Other: immunoenzyme technique Other: laboratory biomarker analysis Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Primary Purpose: Treatment
Official Title: Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies
Study Start Date : December 2001
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Toxicity
  2. Maximum tolerated dose
  3. Survival
  4. Time to failure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00551005

Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Study Chair: Przemyslaw W. Twardowski, MD City of Hope Comprehensive Cancer Center

Responsible Party: City of Hope Medical Center Identifier: NCT00551005     History of Changes
Other Study ID Numbers: 01036
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000570381 ( Registry Identifier: NCI PDQ )
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012

Keywords provided by City of Hope Medical Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents