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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT00033566
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists
* Biopsy-accessible lesion
* No brain metastasis unless clinically stable and off therapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* More than 6 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* Transaminases less than 2.5 times ULN
Renal:
* Creatinine less than 2.0 mg/dL
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 30 days after study
* Able to tolerate oral medication
* HIV negative
* No AIDS
* No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)
* No other serious concurrent illness
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
* Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses
* No other concurrent immunotherapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* At least 4 weeks since prior hormonal therapy
* Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses
* No concurrent hormonal therapy
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* No prior significant gastric resection
Other:
* Recovered from prior therapy
* At least 4 weeks since other prior investigational antitumor drugs
* No other concurrent investigational antitumor drugs
* Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00033566
Study Brief:
Protocol Section:
NCT00033566