NCT00665457

Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery

Terminated Phase 2 Results posted Last updated 13 September 2023

What this trial tests

Phase 2 trial testing filgrastim in Breast Cancer in 3 participants. Terminated before completion.

Timeline

15 April 2004

Primary endpoint
31 July 2009

31 July 2009

Quick facts

Lead sponsor	University of Nebraska
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	15 April 2004
Primary completion	31 July 2009
Estimated completion	31 July 2009
Sites	1 location across United States

Drugs / interventions tested

• filgrastim
• capecitabine (capecitabine) — full drug profile →
• celecoxib (celecoxib) — full drug profile →
• cyclophosphamide (cyclophosphamide) — full drug profile →
• docetaxel (Docetaxel) — full drug profile →
• doxorubicin hydrochloride — full drug profile →
• gene expression analysis
• polymorphism analysis
• protein expression analysis
• reverse transcriptase-polymerase chain reaction
• imaging biomarker analysis
• immunohistochemistry staining method
• laboratory biomarker analysis
• pharmacogenomic studies
• dynamic contrast-enhanced magnetic resonance imaging
• needle biopsy
• neoadjuvant therapy
• radiomammography
• ultrasound imaging

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of Nebraska

Who can join

Adults 19 to 120, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Grade 4 Adverse Events Primary · every 3 weeks X 4, then every 2 weeks X4

Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE.

Group	Value	95% CI
Celecoxib	1

Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure Primary · 20 weeks

CTEP RECIST guidelines are defined as followed: Pathologic complete response is no signs of residual malignancy cells at the primary site and axillary lymph nodes are seen with histologic examination. Progression-free survival is defined as from the first date of therapy until the first notation of clinical progression or relapse. Overall survival is defined as from the first date of therapy until the date of death. Time to treatment failure is defined as from the first date of therapy until the date the patient is removed from study for any reason.

Group	Value	95% CI
Celecoxib	0
Celecoxib	1
Celecoxib	1
Celecoxib	1

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Celecoxib

Serious: 1/3 (33%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Celecoxib
Neutropenic Fever	Immune system disorders	—

Other adverse events (8 terms — click to expand)

Reaction	System	Celecoxib
Paronychia	Immune system disorders	—
Elevated Liver Enzymes	Hepatobiliary disorders	—
Lacrimal Stenosis	Eye disorders	—
Weight Loss	Metabolism and nutrition disorders	—
Dysuria	Renal and urinary disorders	—
Intractable nausea and vomiting	Gastrointestinal disorders	—
Neutropenic fever	Immune system disorders	—
Obstruction nasolacrimal duct	Eye disorders	—

Most-reported serious reactions: Neutropenic Fever.

Data from ClinicalTrials.gov NCT00665457 adverse events section.

Sponsor's own description

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women receiving chemotherapy and celecoxib for stage II or stage III breast cancer that can be removed by surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.