Paclitaxel-based second-line therapy for patients with advanced chemotherapy-resistant bladder carcinoma (M1): a clinical Phase II study.

Abstract:

BACKGROUND:In a previous clinical trial, the authors disclosed that the expression of tumor cell motility factor gp78hAMFR correlates with tumor progression in patients with bladder carcinoma. This study was initiated to evaluate whether the combination of cytostatic drugs with an antimotility factor has an effect on chemotherapy-resistant bladder carcinoma. METHODS:In a Phase II trial, the authors evaluated the influence of paclitaxel, carboplatin, and an antimotility factor (acellular pertussis vaccine [APV]) in 18 patients with cisplatin- and methotrexate-resistant metastatic bladder carcinoma. Intramuscular injection of APV 3 times in the first week, on Days 1, 4, and 7, was followed by paclitaxel 135 mg/m2 and carboplatin 400 mg/m2. After an interval of 1 week APV was given again on Days 15 and 19. Each cycle lasted 3 weeks. On Day 22 the cycle was repeated. RESULTS:Four of 18 patients had objective responses (2 had complete remissions and 2 had partial remissions). After a median number of 2.5 cycles, side effects did not exceed World Health Organization Grade 4. CONCLUSIONS:The results of this clinical Phase II study demonstrate that the combination of paclitaxel-based therapy causes complete remissions previously not obtained with second-line chemotherapy, although no conclusions can be drawn as to the effectiveness of the individual substances. Further trials have to be evaluated with regard to the individual components.

journal_name

Cancer

journal_title

Cancer

authors

Otto T,Bex A,Krege S,Walz PH,Rübben H

doi

10.1002/(sici)1097-0142(19970801)80:3<465::aid-cnc

subject

Has Abstract

pub_date

1997-08-01 00:00:00

pages

465-70

issue

3

eissn

0008-543X

issn

1097-0142

pii

10.1002/(SICI)1097-0142(19970801)80:3<465::AID-CNC

journal_volume

80

pub_type

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