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:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT00080834
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon or rectum
* Progressive locally advanced or metastatic disease
* Received 1 prior irinotecan- or oxaliplatin-containing regimen
* At least 1 measurable lesion
* Target lesion must be outside field of prior radiotherapy
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* ALT and AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Gastrointestinal
* No difficulty with swallowing
* No malabsorption
* No diarrhea (excess of 2-3 stools/day above normal frequency) within the past month
* No history of chronic diarrhea
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No concurrent serious infection
* No other concurrent severe or uncontrolled underlying medical condition that would preclude study participation
* No neuropathy ≥ grade 2
* No history of any severe or life-threatening hypersensitivity reaction
* No psychiatric disorder that would preclude study compliance
* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic therapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior myelosuppressive chemotherapy and recovered
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
* Localized radiotherapy to non-indicator lesions for pain relief allowed provided other methods of pain control are ineffective
Surgery
* At least 4 weeks since prior major surgery and recovered
* No prior major surgery in the stomach or small intestine
Other
* More than 28 days since prior investigational agents (including analgesics and/or antiemetics)
* No other concurrent anticancer therapy
* No other concurrent cytotoxic therapy
* No concurrent grapefruit products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00080834
Study Brief:
Protocol Section:
NCT00080834