A phase 2 study of TZT-1027, administered weekly to patients with advanced non-small cell lung cancer following treatment with platinum-based chemotherapy.
BACKGROUND
: TZT-1027, a derivative of dolastatin-10, has a wide spectrum of in vitro activity against cancer cell lines. We conducted a phase 2 trial of TZT-1027 in patients with previously treated non-small cell lung cancer (NSCLC).


METHODS
Patients with stage IV or recurrent NSCLC who had received one prior platinum-based chemotherapy regimen were eligible. Patients received 2.4mg/m(2) of TZT-1027 on days 1 and 8 of a 21-day cycle. The primary endpoint was response rate as measured by RECIST.


RESULTS
Thirty-two patients were enrolled (16 women, 16 men). The most common grade 3/4 adverse effects were leukopenia and neutropenia. Four patients died within 30 days of receiving TZT-1027, three from progressive disease and one with pneumonia and neutropenia. No objective response was observed (0% observed rate, 95% confidence interval 0-11%). The median time to progression was 1.5 months. The median overall survival was 8.5 months.


CONCLUSIONS
This phase 2 trial showed that TZT-1027 administered on days 1 and 8 of a 21-day cycle had no anticancer activity. Further development of TZT-1027 in patients with previously treated NSCLC is not warranted.
Riely
Gregory J
GJ
Thoracic Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
Gadgeel
Shirish
S
Rothman
Ivan
I
Saidman
Bruce
B
Sabbath
Kert
K
Feit
Kevie
K
Kris
Mark G
MG
Rizvi
Naiyer A
NA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D009842:Oligopeptides; D016190:Carboplatin; C105791:soblidotin