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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00425360
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
* Locally advanced or metastatic disease precluding curative surgical resection
* Unidimensionally measurable disease by CT scan
* No intracerebral metastases or meningeal carcinomatosis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* WBC \> 3,000/mm³
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Bilirubin \< 2.0 mg/dL
* Creatinine clearance \> 50 mL/min
* No medical or psychiatric condition that would preclude giving informed consent
* No clinically significant serious disease or organ system disease not currently controlled on present therapy
* No uncontrolled angina pectoris
* Not pregnant or nursing
* Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment
* No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
* No known malabsorption syndrome
* No known hypersensitivity to any of the investigational agents
* No dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy
* No radiotherapy within the past 4 weeks
* No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)
* Concurrent short-term steroids for palliation of cancer-related symptoms allowed
* No other concurrent investigational drugs or cytotoxic agents
* No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001
* Concurrent low-dose corticosteroids may be allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00425360
Study Brief:
Protocol Section:
NCT00425360