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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT00077259
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum
* Evidence of at least 1 site of unidimensionally measurable disease by radiography or physical examination
* Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan OR oxaliplatin for advanced or metastatic disease
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin ≥ 9 g/dL
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
* Alkaline phosphatase ≤ 5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No New York Heart Association class III or IV congestive heart failure
* No QTc \> 450 msec for males or \> 470 msec for females
* No personal or family history of congenital long QT syndrome
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No pre-existing neuropathy grade 2 or greater
* No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor
* No infection requiring parenteral or oral anti-infective treatment
* No altered mental status or psychiatric condition that would preclude giving informed consent
* No other medical condition that would preclude study participation
* No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a prostate-specific antigen \< 2 ng/mL
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent sargramostim (GM-CSF)
* No concurrent routine prophylactic use of filgrastim (G-CSF)
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* At least 3 weeks since prior radiotherapy and recovered
Surgery
* At least 3 weeks since prior surgery and recovered
Other
* More than 3 weeks since prior investigational agents (therapeutic or diagnostic)
* No other concurrent therapy for advanced or metastatic colorectal cancer
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00077259
Study Brief:
Protocol Section:
NCT00077259