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 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT00004095
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease:
* Bladder cancer - no more than 1 prior therapy
* Breast cancer - no more than 2 prior therapies
* Colorectal cancer - no more than 1 prior therapy
* Kidney cancer - no prior therapy
* Lung cancer - no more than 1 prior therapy
* Pancreatic cancer - no prior therapy
* Bidimensionally measurable disease outside a previously irradiated field
* At least 2 cm x 2 cm
* No known bone metastases
* CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL regardless of liver involvement secondary to tumor
* SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
* No known Gilbert's disease
Renal:
* Creatinine no greater than 1.8 mg/dL
* Calcium less than 12.0 mg/dL
Cardiovascular:
* No myocardial infarction within the past 6 months
* No congestive heart failure requiring therapy
Other:
* No active uncontrolled bacterial, viral (including HIV), or invasive fungal infection
* No psychiatric disorders that would prevent compliance
* No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No history of seizures
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent sargramostim (GM-CSF)
* No concurrent immunotherapy
Chemotherapy:
* No prior irinotecan, topotecan, or gemcitabine
* Prior adjuvant chemotherapy allowed, if at least 1 year between last dose of adjuvant chemotherapy and recurrence of cancer
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy to less than 30% of bone marrow
* No prior whole pelvic radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
Other:
* No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00004095
Study Brief:
Protocol Section:
NCT00004095