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Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of Oral Etoposide in Combination With Celecoxib in Patients With Advanced Malignancies


- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Przemyslaw W. Twardowski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

December 2001

Completion Date:

February 2012

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific