Etoposide and Celecoxib in Patients With Advanced Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 26 November 2012
• Main ID: NCT00551005
• Date of registration: 25/10/2007
• Primary sponsor: City of Hope Medical Center
• Public title: Etoposide and Celecoxib in Patients With Advanced Cancer
• Scientific title: Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies
• Date of first enrolment: December 2001
• Target sample size: 58
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00551005
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Contacts

• Name: Przemyslaw W. Twardowski, MD
• Affiliation: Beckman Research Institute

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Unspecified Adult Solid Tumor, Protocol Specific

Intervention(s)

Drug: celecoxib

Drug: etoposide

Other: immunoenzyme technique

Other: laboratory biomarker analysis

Primary Outcome(s)

Maximum tolerated dose [Time Frame: Yes]

Survival [Time Frame: No]

Time to failure [Time Frame: No]

Toxicity [Time Frame: Yes]

Secondary ID(s)

01036

CDR0000570381

CHNMC-01036

P30CA033572

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)