Etoposide and Celecoxib in Patients With Advanced Cancer

NCT ID: NCT00551005

Last Updated: 2012-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2012-02-29

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

celecoxib

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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 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

• 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

• 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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Przemyslaw W. Twardowski, MD

Role: STUDY_CHAIR

City of Hope Comprehensive Cancer Center

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-01036

Identifier Type: -

Identifier Source: secondary_id

CDR0000570381

Identifier Type: REGISTRY

Identifier Source: secondary_id

01036

Identifier Type: -

Identifier Source: org_study_id