A phase 2 study of TZT-1027, administered weekly to patients with advanced non-small cell lung cancer following treatment with platinum-based chemotherapy Journal Article
| Authors: | Riely, G. J.; Gadgeel, S.; Rothman, I.; Saidman, B.; Sabbath, K.; Feit, K.; Kris, M. G.; Rizvi, N. A. |
| Article Title: | A phase 2 study of TZT-1027, administered weekly to patients with advanced non-small cell lung cancer following treatment with platinum-based chemotherapy |
| Abstract: | Introduction: : 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). Patients and methods: Patients with stage IV or recurrent NSCLC who had received one prior platinum-based chemotherapy regimen were eligible. Patients received 2.4 mg/m2 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. © 2006 Elsevier Ireland Ltd. All rights reserved. |
| Keywords: | adult; cancer chemotherapy; cancer survival; clinical article; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; survival rate; overall survival; clinical trial; constipation; fatigue; neutropenia; cancer growth; diarrhea; drug dose reduction; drug efficacy; antineoplastic agents; cancer patient; cancer staging; outcome assessment; recurrent cancer; neoplasm staging; anorexia; carboplatin; multiple cycle treatment; phase 2 clinical trial; anemia; leukopenia; lung non small cell cancer; nausea; neuropathy; thrombocytopenia; carcinoma, non-small-cell lung; lung neoplasms; arthralgia; drug dose escalation; febrile neutropenia; confidence interval; drug fatality; disease severity; disease progression; carcinoma; recurrent disease; platinum; injection site pain; drug dose increase; recombinant granulocyte colony stimulating factor; alopecia; oligopeptides; ileus; recombinant granulocyte macrophage colony stimulating factor; clinical trials; dysgeusia; dolastatin-10; phase 2; non-small cell; soblidotin; tzt-1027; auristatin pe |
| Journal Title: | Lung Cancer |
| Volume: | 55 |
| Issue: | 2 |
| ISSN: | 0169-5002 |
| Publisher: | Elsevier Ireland Ltd. |
| Date Published: | 2007-02-01 |
| Start Page: | 181 |
| End Page: | 185 |
| Language: | English |
| DOI: | 10.1016/j.lungcan.2006.10.002 |
| PUBMED: | 17092603 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 14" - "Export Date: 17 November 2011" - "CODEN: LUCAE" - "Source: Scopus" |
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