A phase II study of weekly paclitaxel, cisplatin and concurrent radiation therapy for locally-advanced unresectable non-small cell lung cancer: early closure due to lack of efficacy.
OBJECTIVE
In this phase II study, the efficacy and safety of weekly paclitaxel concomitant with cisplatin and thoracic radiotherapy (TRT) was evaluated in patients with locally-advanced unresectable non-small cell lung cancer (NSCLC).


METHODS
Patients with stage III NSCLC (without pleural effusion or cervical lymphadenopathy) received TRT (63 Gy in 35 fractions over 7 weeks) with concurrent weekly cisplatin 20 mg/m(2) and paclitaxel 40 mg/m(2)/week infused over 3 hours. In patients without evidence of disease progression, the administration of a further 2 cycles of consolidation chemotherapy, consisting of paclitaxel 175 mg/m(2) and cisplatin 75 mg/m(2), were planned after completion of the TRT.


RESULTS
Between Feb 2000 and Dec 2002, 20 patients were entered into the study; 13 completed all 7 weeks of treatment (median 7.6 weeks; range 3.3 to 9.4). Seven out of 16 (43.8%) objective responses were observed, with 15 (75%) patients experiencing at least one episode of grade 3/4 toxicity. The main toxicities were moderate to severe neutropenia and gastrointestinal toxicity.


CONCLUSIONS
The unsatisfactory response rate and the high incidence of grade 3/4 hematologic and non-hematologic toxicities, including 7 early discontinuations of treatment and exceeding the study stopping rules, prompted the early closure of the study. In view of the activity observed, the protocol was amended to protracted continuous infusion paclitaxel, cisplatin and concurrent TRT.
Park
Se Hoon
SH
Department of Internal Medicine, Gachon Medical School Gil Medical Center, Incheon, Korea.
Kim
Mi Kyung
MK
Kyung
Sun Young
SY
Lim
Young-Hee
YH
An
Chang Hyeok
CH
Park
Jeong Woong
JW
Jeong
Seong Hwan
SH
Lee
Jae Woong
JW
Lee
Kyu Chan
KC
Cho
Eun Kyung
EK
Bang
Soo Mee
SM
Shin
Dong Bok
DB
Lee
Jae Hoon
JH