| Exclusion Criteria: | Pregnant or lactating women.
Women of childbearing potential with either a positive or no pregnancy test at baseline.
Women of childbearing potential unless using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
Chemotherapy within 4 weeks preceding treatment start.
Prior treatment w/more than 2 regimens of chemotherapy in advanced/metastatic (non-adjuvant) setting. It is recommended that pts should have received no more than 1 regimen for advanced and/or metastatic disease if they have relapsed during or within 2 years of completing anthracycline-based adjuvant chemotherapy.
Prior treatment with continuous (greater than 24h) 5-FU infusion, capecitabine or other oral fluoropyrimidines such as eniluracil/5-FU , uracil/tegafur, S1 or emitefur. Bolus 5-FU regimens (such as CMF) are acceptable.
Prior treatment with a docetaxel-containing regimen in the advanced/metastatic disease setting. Pts may have received docetaxel in either the neoadjuvant or adjuvant setting as long as a minimum of 12 months have passed from the time of therapy completion to relapse. Prior treatment with paclitaxel is allowed.
Mitomycin C or Nitrosoureas within 6 weeks preceding treatment start.
Organ allografts (excluding bone marrow auto- or allografts).
Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy.
Hormonal therapy within 10 days preceding study treatment start.
Incomplete recovery from the effects of major surgery.
Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start.
Participation in any investigational drug study within 4 weeks preceding treatment start.
Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency).
Known hypersensitivity to 5-fluorouracil, any of the components of capecitabine or docetaxel.
Severe renal impairment (creatinine clearance less than 30 mL/min [calculated according to Cockroft and Gault, see Section 4 of the SPAM]).
Evidence of CNS metastases. Pts w/a history of uncontrolled seizures, CNS disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance should be excluded from the study.
History of another malignancy within the last 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer.
Clinically significant (i.e. active) cardiac disease (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
Abnormal lab values: hemoglobin equal to or less than 8.0 g/dl- neutrophils equal to or less than 1.5 x 10(9)/L- platelet count equal to or less than 100 x 10(9)/L- serum creatinine equal to or greater than 1.5 x (ULN)- serum bilirubin greater than ULN- ALAT(SGPT) and/or ASAT(SGOT) greater than 5 x ULN (1.5 if alkaline phosphatase is concomitantly elevated equal to or greater than 2.5 x ULN)
Serious uncontrolled intercurrent infections.
Lack of physical integrity of the upper gastrointestinal tract or those who have clinically significant malabsorption syndrome.
Inability to swallow tablets.
Life expectance of less than 3 months.
Unwilling or unable to comply with the protocol for the duration of the study.
Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
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