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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT00987766
Eligibility Criteria:
Inclusion Criteria:
* Only advanced carcinomas defined as unresectable or metastatic that are histologically or cytologically confirmed to be biliary tract, pancreas, duodenal, or ampullary carcinomas will be included.
* Dose-escalation: Patients \> 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma, pancreas cancer, duodenal cancer, or ampullary cancer
* MTD expansion cohort: Patients \> 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma only.
* No prior chemotherapy or prior EGF receptor inhibitor therapy
* Measurable tumor by imaging examination
* Performance status (PS) 0-2 on the ECOG performance scale
* Have pretreatment bilirubin\<2.5x upper limit of normal (ULN), serum creatinine\<1.5x ULN, AST and ALT \<2.5xULN or in the presence of liver metastasis \<5xULN, neutrophils\>1500, platelets\>100K, hemoglobin \>9 g/dL
* Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
* Have the ability to understand the requirements of the study and provide informed consent
Exclusion Criteria:
* CNS metastases
* Uncontrolled infection
* Pregnant or nursing women may not participate.
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
* Psychiatric illness that would prevent understanding the nature of the investigational therapy and complying with protocol requirements
* Patients with \> grade 2 neuropathy
* Patients with \> grade 2 uncontrolled nausea and vomiting despite antiemetics
* Any concurrent medical condition that, in the judgment of the investigator, would make the patient an inappropriate candidate for study enrollment
* Prior chemotherapy or EGFR inhibitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00987766
Study Brief:
Protocol Section:
NCT00987766