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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00072332
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Histologically or cytologically confirmed active solid tumor malignancy
* Histologically confirmed esophageal or gastric cancer\* meeting all the following criteria:
* Previously untreated disease
* Metastatic disease
* Measurable disease
* At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR 10 mm by spiral CT scan NOTE: \*Patients with esophageal or gastric cancer are enrolled after the maximum tolerated dose has been determined
* No known brain or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN) (regardless of liver involvement by tumor)
* SGOT no greater than 3 times ULN (5 times ULN if there is liver involvement by tumor)
* Albumin at least 3.0 g/dL
Renal
* Creatinine no greater than 1.5 mg/dL
Cardiovascular
* None of the following within the past 12 months:
* Myocardial infarction
* Severe/unstable angina
* Symptomatic congestive heart failure
* Cerebrovascular accident
* Transient ischemic attack
* Deep vein thrombosis
* Other significant thromboembolic event
* No ongoing grade 2 or greater cardiac dysrhythmia
* No atrial fibrillation
Pulmonary
* No pulmonary embolism within the past 12 months
Gastrointestinal
* No active inflammatory bowel disease
* No partial or complete bowel obstruction
* No chronic diarrhea
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No grade 2 or greater acute toxic effects
* No active infection
* No other concurrent acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior treatment with any of the following systemic therapies for metastatic cancer\*:
* Antibody therapy
* Immunotherapy
* Gene therapy
* Vaccine therapy
* Cytokine therapy
* Inhibitors of vascular endothelial growth factor/Flk-1 pathway
* No concurrent sargramostim (GM-CSF)
* No concurrent antibody therapy or immunotherapy NOTE: \*Patients with esophageal or gastric cancer only
Chemotherapy
* No more than 1 prior chemotherapy regimen for metastatic disease\*
* No prior high-dose chemotherapy requiring hematopoietic stem cell rescue
* No other concurrent chemotherapy NOTE: \*No prior chemotherapy for metastatic disease for patients with esophageal or gastric cancer
Endocrine therapy
* No concurrent hormonal treatment
Radiotherapy
* No prior radiotherapy to more than 25% of bone marrow reserve
* No prior radiotherapy to the sole measurable lesion\*
* No concurrent radiotherapy NOTE: \*Patients with esophageal or gastric cancer only
Surgery
* More than 12 months since prior coronary/peripheral artery bypass graft surgery
Other
* Recovered from prior therapy
* More than 6 months since last dose of prior adjuvant therapy\*
* No prior treatment with any of the following systemic therapies for metastatic cancer\*:
* Cyclooxygenase-2 inhibitors
* Matrix metalloprotease inhibitors
* Epidermal growth factor receptor inhibitors
* Other experimental agents
* No other concurrent anticancer therapy
* No concurrent enrollment in another clinical trial
* No other concurrent experimental drugs NOTE: \*Patients with esophageal or gastric cancer only
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00072332
Study Brief:
Protocol Section:
NCT00072332