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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


OBJECTIVES:

- To describe the toxicities of oral cyclophosphamide when administered with escalating
doses of celecoxib in patients with advanced malignancies.

- To evaluate the effects of this regimen on plasma levels of vascular endothelial growth
factor.

OUTLINE: This is a dose-escalation study of celecoxib.

In the first course, patients receive oral cyclophosphamide once daily on days 1-35 and oral
celecoxib twice daily on days 8-35. In all subsequent courses, patients receive oral
cyclophosphamide 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 and stored
for future analysis of circulating DNA of angiogenic biomarkers.

After completion of study therapy, patients are followed periodically.

Inclusion 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 that, at the time of study enrollment, are controlled
and do not require treatment with corticosteroids are eligible

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 or ALT < 2.0 times upper limit of normal (unless clearly due to the presence of
tumor)

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Patient must be capable of understanding the nature of the trial and must give
written informed consent

- No unstable or severe intercurrent medical conditions or active, uncontrolled
infection

- No history of allergic reactions to nonsteroidal anti-inflammatory drugs

- No bleeding peptic ulcer within the past 3 months

- No allergy to sulfa drugs

PRIOR CONCURRENT THERAPY:

- Recovered from all prior therapy

- No radiotherapy or chemotherapy within the 3 weeks (nitrosoureas or mitomycin C
within 6 weeks) prior to anticipated first day of dosing

- No concurrent therapy with other investigational agents or antineoplastic therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Toxicity

Safety Issue:

Yes

Principal Investigator

Przemyslaw W. Twardowski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

00191

NCT ID:

NCT00551889

Start Date:

September 2001

Completion Date:

February 2012

Related Keywords:

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

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