Etoposide and Celecoxib in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00551005
First received: October 25, 2007
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Survival [ Designated as safety issue: No ]
  • Time to failure [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: December 2001
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551005

Sponsors and Collaborators
City of Hope Medical Center
Investigators
Study Chair: Przemyslaw W. Twardowski, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00551005     History of Changes
Other Study ID Numbers: 01036, P30CA033572, CHNMC-01036, CDR0000570381
Study First Received: October 25, 2007
Last Updated: November 21, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Etoposide
Etoposide phosphate
Celecoxib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014