Etoposide and Celecoxib in Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib; Etoposide; Etoposide phosphate

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