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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT00068432
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic pancreatic cancer
* Radiographic evidence of disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Gastrointestinal
* No history of peptic ulcer disease
* No gastrointestinal bleeding within the past 3 months
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reactions to compounds of similar chemical or biological composition to study drugs or to sulfonamides
* No prior allergic reaction, asthma, or urticaria after taking aspirin or NSAIDs
* No ongoing or active infection
* No other uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for metastatic pancreatic cancer
* More than 6 months since prior neoadjuvant or adjuvant chemoradiotherapy (including gemcitabine) for pancreatic cancer
Endocrine therapy
* Not specified
Radiotherapy
* See Chemotherapy
* More than 6 months since prior radiotherapy
Surgery
* Not specified
Other
* More than 30 days since prior investigational agents
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
* No other concurrent cyclo-oxygenase-2 (COX-2) inhibitors (e.g., rofecoxib)
* Concurrent acetaminophen-containing medications or low-dose aspirin (up to 325 mg/day) for cardiac prophylaxis allowed
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00068432
Study Brief:
Protocol Section:
NCT00068432