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Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors

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

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Trial Information

Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors



- Determine the maximum tolerated dose (MTD) of bortezomib and celecoxib in patients with
advanced solid tumors.


- Determine the overall pattern of toxicities associated with this combination, including
the emergence of any cumulative toxicities, during multiple courses of this regimen.

- Describe the response rate and duration of response or disease stability during therapy
in the subset of patients with measurable disease.

- Assess changes in plasma/serum sphingosine-1-phosphate, ceramide, and other markers of
the apoptotic pathway before and during therapy.

OUTLINE: This is a dose-escalation study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 or days 1, 8, 15, 22, and 29 and oral
celecoxib twice daily on days 1-21 or 1-42. Courses repeat every 21 or 42 days in the
absence of disease progression or unacceptable toxicity. Patients are evaluated every 2
courses. Patients achieving complete response (CR) receive 2 additional courses of therapy
beyond CR.

Cohorts of 3-6 patients receive escalating doses of bortezomib and celecoxib until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Inclusion Criteria


- Histologic or cytologic diagnosis of a malignant neoplasm (solid tumor) arising from
any primary site with the exception of bone marrow or lymphoid tissue

- Recurrent or progressive disease after chemotherapy or radiotherapy

- Chemotherapy or radiotherapy-naive disease allowed if patient is not a candidate
for standard treatment either due to comorbidities or lack of willingness to
undergo standard treatment

- Measurable disease


- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min

- Bilirubin ≤ 2 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active concurrent invasive malignancy

- No peripheral neuropathy ≥ grade 2 within the past 14 days

- No hypersensitivity to bortezomib, boron, mannitol, any of the cyclooxygenase (COX-2)
inhibitors, sulfa drugs, or other nonsteroidal anti-inflammatory drugs (NSAIDs)

- No active gastrointestinal (GI) ulcers OR history of GI bleeding resulting from prior
therapy with NSAIDs


- At least 2 weeks since completion of prior radiotherapy

- No prior bortezomib

- No other concurrent investigational agents

- No concurrent chemotherapy, radiotherapy, or anticancer surgery

- No concurrent immune-enhancing therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Andrew S. Kraft, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina


United States: Federal Government

Study ID:




Start Date:

March 2005

Completion Date:

January 2009

Related Keywords:

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



Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425