In this phase I/II clinical trial the antitumor activity of high-dose @entity440 when administered in combination with @entity5713 was assessed and the @entity137 profile of this combination characterized. All 25 @entity1 enrolled in this study were required to have @entity342 -independent @entity263 and to maintain @entity342 ablation during treatment. @entity5713 was given by continuous infusion over 5 days. Doses were increased from 0.9 mg/m2/day to 1.5 mg/m2/day in successive cohorts of at least 3 @entity1 , with no further escalation even in the absence of dose-limiting @entity137 . Intra- @entity1 dose escalation was permitted. @entity440 was administered at a dose of 200 mg/kg on day 1, then 120 mg/kg/day on day 2. Standard response criteria were utilized to assess antitumor activity and CTC @entity137 criteria were used. Quality of life (QOL) @entity158 assessments were evaluated at each visit to the clinic. Most @entity1 tolerated the highest dose of @entity5713 at 1.5 mg/m2/day by continuous infusion over 5 days with 200 mg/kg/day of @entity440 on day 1 and day 2. One @entity1 had a greater than 50% decline in prostate-specific antigen that lasted for 170 days. Two @entity1 received dose reductions because of @entity137 . The most common serious @entity137 included @entity1398 , and @entity1295 . Reversible neurosensory, neuromotor, neurocortical and @entity137 were reported. Six of the 25 @entity1 enrolled in the study (24%) experienced reversible @entity137 of at least grade III. No statistically significant differences between precycle assessment of QOL and subsequent cycles were observed. It is concluded that @entity5713 at 1.5 mg/m2/day continuous i.v. infusion combined with @entity440 200 mg/kg/day on day 1 and day 2 is inactive, and not without @entity137 in the treatment of advanced metastatic @entity342 -independent @entity263 .

A phase I/II study of high-dose @entity440 in combination with @entity5713 in XXXX with @entity342 -independent @entity263 .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'neurocerebellar toxicities', 'neurologic toxicity', 'toxicities'] @entity263 :: ('MESH:D011471', 'Disease') :: ['prostate cancer'] @entity440 :: ('MESH:D013629', 'Chemical') :: ['tamoxifen', 'Tamoxifen'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity342 :: ('CHEBI:50113', 'Chemical') :: ['androgen'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity5713 :: ('MESH:D014747', 'Chemical') :: ['vinblastine', 'Vinblastine']
@entity1 :: (9606,Species) :: ['patients']
