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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT00107250
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Non-small cell lung cancer (NSCLC) (closed to accrual as of 8/9/07) meeting 1 of the following stage criteria:
* Stage IIIB disease
* Patients without pleural effusion who are not candidates for combined modality treatment OR who were treated at centers where combined modality treatment is not considered standard treatment are eligible
* Stage IV disease
* Local or metastatic failure after prior surgery and/or radiotherapy
* Colorectal cancer
* Metastatic disease
* Considered suitable for first-line therapy with capecitabine
* Other tumor types
* Suitable for treatment with capecitabine
* No more than 2 prior chemotherapy regimens for advanced or metastatic disease
* Incurable by radiotherapy or surgery
* Clinically or radiologically documented disease
* No tumor marker elevation as the only evidence of disease
* No necrotic or hemorrhagic tumor or metastases
* No untreated brain or meningeal metastases
* Patients with previously treated stable brain metastases (by radiography or clinical exam) are eligible provided they are asymptomatic and do not require corticosteroids
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks (colorectal cancer patients)
Hematopoietic
* Hemoglobin adequate
* Anemia allowed provided patient is well compensated with no evidence of recent bleeding
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No overt bleeding (i.e., ≥ 30 mL/episode) within the past 3 months
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT or AST ≤ 2 times ULN (5 times ULN for documented liver metastases)
Renal
* Creatinine ≤ 1.5 times ULN OR
* Creatinine clearance ≥ 50 mL/min
* No proteinuria \> grade 1
Cardiovascular
* Resting systolic blood pressure ≤ 150 mm Hg AND/OR resting diastolic blood pressure ≤ 100 mm Hg (in the presence or absence of a stable dose of antihypertensive medication)
* Mean QTc ≤ 470 msec (with Bazetts correction) by ECG
* LVEF \> 50% for patients with prior anthracyclines/trastuzumab or cardio-toxic agents
* No untreated or uncontrolled cardiovascular condition
* No symptomatic cardiac dysfunction
* No poorly controlled hypertension
* No history of labile hypertension
* No history of poor compliance with antihypertensive medication
* No history of familial long QT syndrome
Pulmonary
* No clinically relevant hemoptysis (i.e., ≥ 5 mL fresh blood) within the past 4 weeks
* Patients with only flecks of blood in their sputum are eligible
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective (double-method for females; barrier method for males) contraception
* No prior allergic reaction to drugs containing Cremophor EL® (NSCLC patients \[closed to accrual as of 8/9/07\])
* No peripheral neuropathy \> grade 1 (NSCLC patients \[closed to accrual as of 8/9/07\])
* No dihydropyrimidine dehydrogenase deficiency (colorectal cancer patients)
* No history of severe hand-foot syndrome after treatment with fluoropyrimidines (colorectal cancer patients)
* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor
* No active or uncontrolled infection
* No other serious illness or medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior antiangiogenesis therapy
Chemotherapy
* At least 4 weeks since prior single-agent non-platinum-containing chemotherapy (6 weeks for nitrosoureas or mitomycin) for metastatic disease (NSCLC patients \[closed to accrual as of 8/9/07\])
* No more than 1 prior single-agent non-platinum-containing chemotherapy regimen for metastatic disease
* At least 6 months since prior adjuvant or neoadjuvant chemotherapy
* No prior taxane therapy (NSCLC patients \[closed to accrual as of 8/9/07\])
* No prior chemotherapy for metastatic disease (colorectal cancer patients)
* No prior capecitabine (colorectal cancer patients)
Endocrine therapy
* See Disease Characteristics
* At least 4 weeks since prior corticosteroids
Radiotherapy
* See Disease Characteristics
* At least 21 days since prior palliative radiotherapy except for low-dose non-myelosuppressive radiotherapy with approval
* At least 6 months since prior adjuvant radiotherapy
Surgery
* See Disease Characteristics
* At least 14 days since prior major surgery
Other
* Recovered from prior therapy
* At least 14 days since prior epidermal growth factor receptor inhibitor therapy
* Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is strictly monitored
* No other concurrent investigational therapy
* No other concurrent anticancer therapy
* No concurrent prophylactic pyridoxine (vitamin B\_6) for hand-foot syndrome (colorectal or other tumor type patients)
* Use of pyridoxine after the onset of hand-foot syndrome allowed at the discretion of the physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00107250
Study Brief:
Protocol Section:
NCT00107250