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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT00033306
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic colorectal adenocarcinoma
* Prior treatment for metastatic disease with at least:
* One regimen of irinotecan in combination with a fluoropyrimidine OR
* Two regimens comprising fluoropyrimidine-based first-line therapy and irinotecan-based second-line therapy
* May have received cetuximab and/or a fluoropyrimidine as part of second- line therapy
* Disease progression during or within 4 months of treatment with irinotecan
* At least 1 bidimensionally measurable lesion
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count greater than 125,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present)
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known prior severe hypersensitivity reactions to agents containing Cremophor EL
* No motor or sensory neuropathy grade 2 or greater
* No concurrent serious uncontrolled infection or other nonmalignant medical illness
* No concurrent psychiatric disorders or other conditions that would preclude study compliance
* No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No concurrent immunotherapy
* No growth factors for 24 hours before and after cytotoxic chemotherapy
Chemotherapy:
* See Disease Characteristics
* Additional prior adjuvant or neoadjuvant chemotherapy allowed
* At least 4 weeks since prior chemotherapy and recovered
* No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease
* No prior oxaliplatin
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except hormone replacement therapy
Radiotherapy:
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to target lesion unless the lesion has shown progression after completion of radiotherapy
* No concurrent therapeutic radiotherapy
* Focal radiotherapy for palliation of bone symptoms may be allowed
Surgery:
* At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered
Other:
* No other concurrent experimental anticancer medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00033306
Study Brief:
Protocol Section:
NCT00033306