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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00754494
Eligibility Criteria:
Inclusion Criteria:
* Participants with one or more of the following criteria will be eligible to participate:
* History of Stage I-III colorectal cancer, not treated in the past 6 months with no anticipated treatment in the next 3 months
* Adenoma ≥ 1 cm in size
* 3 or more adenomas (of any size) removed at one colonoscopy within past 6 years
* Sessile serrated adenoma ≥ 5 mm in size
* Adenoma (of any size) with villous features (villous, tubulovillous)
* Adenoma (of any size) with high grade dysplasia
* Participants are eligible for randomization into the treatment phase of the trial if they are found to have ≥ 4 ACFs at either baseline colonoscopy or baseline flexible sigmoidoscopy
* Blood tests at screening which meet the following criteria:
* WBC \> 3000/mm\^3
* Platelets \> 100,000/mm\^3
* Hemoglobin \> 10g/dl
* Plasma creatinine of \< 1.6mg/dl
* Total bilirubin \< 1.5 x the upper limit of normal
* Serum ALT \< 1.5 x the upper limit of normal
* Serum AST \< 1.5 x the upper limit of normal
* ECOG performance status 0-1
* Women of child-bearing potential and men taking study drug must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
* Ability to understand, as well as sign the written informed consent document
* If a woman is of child-bearing potential, she must have a negative pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Exclusion Criteria:
* History of Inflammatory Bowel Disease (IBD)
* History of interstitial lung disease or chronic lung disease
* Smoking within the past 3 months
* Increased bleeding risk from rectal biopsy (Patients receiving aspirin or plavix can be enrolled)
* Patients receiving warfarin or coumadin
* Uncontrollable diarrhea of any cause
* Patients, including rectal cancer patients, that have received prior radiation to the rectum or pelvis
* Participants taking a known significant CYP 3A4 inducer or inhibitor; known significant inducers/inhibitors include: amprenavir, aprepitant, atazanavir, carbamazepine, clarithromycin, conivaptan, diltiazem, darunavir/ritonavir, dronedarone, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenytoin, posaconazole, rifampin, ritonavir, St. John's wort, saquinavir, telithromycin, tipranavir/ritonavir, verapamil, voriconazole
* Women who are pregnant or breast-feeding
* Active keratoconjunctivitis, or corneal surgery in the past three weeks
* Any medical or psychosocial condition that could jeopardize the subject's participation in and compliance to the study
* Participants who are taking any other investigational pharmaceutical agents
* Previous history of sensitivity to erlotinib, Iressa, or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00754494
Study Brief:
Protocol Section:
NCT00754494