Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00258232
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon or rectum
* Locally recurrent or metastatic disease
* Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
* Bone metastases, ascites, and pleural effusion are not considered measurable disease
* Measurable lesions must be located outside a previously irradiated field
PATIENT CHARACTERISTICS:
Performance status
* SWOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin normal
* No Gilbert's disease
Renal
* Creatinine clearance \> 50 mL/min
Cardiovascular
* No clinically significant cardiac disease that is not well controlled by medication, including any of the following conditions:
* Congestive heart failure
* Symptomatic coronary artery disease
* Cardiac arrhythmias
* No myocardial infarction within the past year
Gastrointestinal
* Must have a physically intact upper gastrointestinal tract
* Able to swallow tablets
* No history of peptic ulcer disease or gastroesophageal reflux
* No malabsorption syndrome
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or other nonsteroidal anti-inflammatory drugs
* No other malignancy except curatively treated cancer with no evidence of active disease
* No unresolved bacterial infection requiring antibiotics
* No other serious infection
* No known allergy to study drugs or sulfa drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for colorectal cancer
* Patients relapsing \> 6 months after completion of prior adjuvant chemotherapy allowed
* No other concurrent anticancer chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* No concurrent anticancer radiotherapy
Surgery
* Recovered from prior surgery
* No concurrent anticancer surgery
Other
* Prior celecoxib for nonmalignant disorders allowed
* No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs, including any of the following:
* Rofecoxib
* Ibuprofen
* Naproxen
* Etodolac
* Oxaprozin
* Diflunisal
* Nabumetone
* Tolmetin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00258232
Study Brief:
Protocol Section:
NCT00258232