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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00871169
Eligibility Criteria:
Inclusion Criteria:
1. All patients, 18 years of age or older, with histology proven pancreatic cancer are eligible.
2. Patients must have a life expectancy of at least 12 weeks.
3. Patients must have a Zubrod performance status of 0-2.
4. Patients must sign an informed consent.
5. Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \>= 1,500 or cells/mm3 and platelet count \>= 60,000/mm3 and absence of a regular red blood cell transfusion requirement.
6. Patients should have adequate hepatic function with a total bilirubin \<= 4.0 mg/dl, could be \<= 10 mg/ml if biliary drainage tube is placed and functional in a newly diagnosed patient, and SGOT or SGPT \<= four times the upper limit of normal, and adequate renal function as defined by a serum creatinine \<= 1.5 x upper limit of normal.
7. For patients that had been treated with one of the study medications will be allowed as long as the treatment did not contain more than 2 study medications at the same time. For example, irinotecan and capecitabine combination will be allowed but not irinotecan and cetuximab. Similarly, gemcitabine with cetuximab will be allowed but not gemcitabine, oxaliplatin and cetuximab. Treated with irinotecan alone followed by oxaliplatin will be allowed but not when irinotecan was in combination with oxaliplatin.
8. Patients are allowed to have up to 2 prior treatments. The protocol will also include chemotherapy naïve patients.
Exclusion Criteria:
1. Patients with symptomatic brain metastases are excluded from this study.
2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
3. Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
4. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
5. Known hypersensitivity reaction to any of the study medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00871169
Study Brief:
Protocol Section:
NCT00871169