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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT00020761
Eligibility Criteria:
Inclusion Criteria
* Patients with histologic proof of adenocarcinoma of the esophagus (including GE junction) or adenocarcinoma of the stomach will be eligible.
* Location of the tumor for assignment to study will be determined by prior endoscopy or barium contrast study.
* Patients must have either metastatic or recurrent cancer.
* Patients must have bidimensionally measurable disease, as defined in Section 8.4.1.1, page 16. Mediastinal or hilar lymph nodes assessed by CT or MRI scans must be at least 2 cm in the largest dimension to be considered measurable.
* Prior limited radiation therapy is permitted. Prior radiotherapy must not have included major bone marrow containing areas (pelvis, lumbar spine), or contained the single evaluable lesion in a radiation field. A recovery period of at least 4 weeks after completion of radiotherapy is required prior to study treatment.
* Patients must have an anticipated life expectancy of at least 12 weeks.
* Patients must have a performance status of 0 or 1 on the ECOG performance scale.
* Patients must be \> 18 years old.
* Patients must give written informed consent prior to enrollment.
* Patients should have adequate organ function defined as follows: Absolute granulocytes \> 1,500/mm3 and platelets \> 100,000/mm3; serum bilirubin \< 1.5 mg/dL and SGOT \< 3X upper limit of institutional norm; and serum creatinine \< 1.5 mg/dL.
* Patients must have recovered from recent surgery. One week must have elapsed from the time of a minor surgery and 3 weeks from major surgery.
Exclusion Criteria
* Patients who have received more than one prior chemotherapy regimen or immunotherapy for metastatic disease. Prior 5-FU alone as an adjuvant therapy or radiosensitizer is not counted. Patients must have an interval of 4 weeks from prior chemotherapy or immunotherapy with full recovery.
* Patients receiving concurrent chemotherapy, immunotherapy, or radiotherapy.
* Patients who are potentially curable with a chemotherapy, radiotherapy, surgery, or any combination of the above.
* Patients with known brain metastases.
* Patients with a history of seizures or are receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis.
* Pregnant or lactating women. All women of childbearing potential must have a negative pregnancy test prior to entry into the study. All patients of procreative potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
* Patients with serious intercurrent infections, or any other concurrent disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
* Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
* Patients with osseous metastasis as only site of disease.
* Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.
* Patients with known Gilbert's syndrome.
* Patients who have a significant clinical neuropathy of greater than grade 2.
* Patients with unstable angina, a history of myocardial infarction within the previous 6 months, or current clinical evidence of congestive heart failure. Patients taking medication for congestive heart failure and showing no clinical signs or symptoms are eligible.
* Patients who have previously received a taxane or campthothecin
* Patients who have received any investigational therapy within the previous 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00020761
Study Brief:
Protocol Section:
NCT00020761