A preliminary report of a phase II trial of single-agent vinflunine as second-line treatment of advanced non-small cell lung cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18156-18156
Author(s):  
M. Joppert ◽  
R. Boccia ◽  
S. Dakhil ◽  
R. Steis
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Single Agent ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung

18156 Background: In preclinical and early clinical trials, single-agent vinflunine (a novel microtubule inhibitor) has shown activity in a variety of tumors, including non-small cell lung cancer (NSCLC). The purpose of this phase II, single-arm study is to evaluate the safety and efficacy of vinflunine administration every 3 weeks to patients with advanced NSCLC who have progressed after prior treatment with a platinum-based doublet. The primary endpoint is 1-year survival rate. This report presents preliminary safety information demonstrating the safety and tolerability of this combination. Methods: Patients = 18 years with confirmed advanced NSCLC (stage IIIB with malignant pleural effusions or stage IV) that have progressed after receiving a platinum-based doublet as first-line therapy, received vinflunine (320 mg/m2) as a 20-minute IV infusion on Day 1 of each 21-day cycle. Results: At the time of analysis, 36 patients (of a planned total of 75) have received study treatment. Patient characteristics include: gender male/female, 24/12; median age 68.5 years (range 42–86); ECOG performance status 0/1, 10/26; and race Caucasian/Black, 34/2. The median number of cycles administered was 2 (range 1–9). Fourteen patients are still on study. The most common toxicities (NCI CTC version 2), regardless of causality, were Grade 3 fatigue (14.3%), asthenia (8.6%), neutropenia (8.6%), constipation (5.7%), cough (5.7%), dehydration (5.7%), vomiting (5.7%), dyspnea (5.7%), and ileus (5.7%). Grade 4 toxicities were neutropenia (22.9%) and change in mental status (5.7%). There were 5 deaths (2 from progressive disease, 1 from respiratory distress, 1 from coronary artery disease, and 1 case of sepsis possibly related to study drug). Conclusions: These preliminary results suggest that vinflunine has a manageable safety profile when used as a single agent for second-line treatment of patients with advanced NSCLC. Supported by Bristol-Myers Squibb. [Table: see text]

scholarly journals A Phase II Study of Single-Agent Gemcitabine as a Second-Line Treatment in Advanced Non-Small Cell Lung Cancer

2006 ◽  
Vol 36 (1) ◽  
pp. 50-54 ◽  
Author(s):  
Keun-Hyok Cho ◽  
Young-Bong Song ◽  
Ik-Sung Choi ◽  
Eun-Hee Cho ◽  
Jae-Won Choi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Phase Ii Study ◽  
Single Agent ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung

Phase II Study of Paclitaxel, Ifosfamide, and Cisplatin as Second-Line Treatment in Relapsed Small-Cell Lung Cancer

2001 ◽  
Vol 19 (1) ◽  
pp. 119-126 ◽  
Author(s):  
Christos Kosmas ◽  
Nicolas B. Tsavaris ◽  
Nikolaos A. Malamos ◽  
Maria Vadiaka ◽  
Christos Koufos
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Phase Ii Study ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung ◽  
Grade 3

PURPOSE: The aim of the present phase II study was to evaluate the efficacy of the paclitaxel, ifosfamide, and cisplatin (PIC) combination in relapsed small-cell lung cancer (SCLC). PATIENTS AND METHODS: Eligible patients were those with SCLC who had progressed or relapsed after therapy with carboplatin and etoposide (with or without chest radiotherapy). The PIC regimen consisted of paclitaxel 175 mg/m2 on day 1, ifosfamide 5 g/m2 divided over days 1 and 2, and cisplatin 100 mg/m2 divided over days 1 and 2; PIC was given every 21 days with granulocyte colony-stimulating factor support. RESULTS: Thirty-three patients (30 men and three women) were entered onto the study (median age, 62 years [range, 55 to 70 years]; median performance status, 1 [range, 0 to 2]). Metastatic sites at study entry included the lymph nodes (n = 13 patients), bone (n = 9), liver (n = 5), brain (n = 6), lung nodules (n = 8), adrenal glands (n = 9), and other (n = 2) Responses included eight complete remissions and 16 partial remissions (overall response rate, 73% [24 of 33 patients]). Five patients had stable disease and two had progressive disease. Median time to progression and overall survival were 21 and 28 weeks, respectively. The 1-year survival rate was 12%, with two patients alive without evidence of disease at 76 and 104 weeks since PIC initiation. Grade 3 and 4 toxicities included neutropenia in 30 patients (24 [73%] developed grade 4 neutropenia [ < 5 days]) and febrile neutropenia in six patients (18%); grade 3 or 4 thrombocytopenia was seen in nine patients (27%) . No grade 3 neuropathy was observed; grade 1 or 2 CNS toxicity was seen in five patients, there was no renal toxicity, grade 2 myalgias were seen in nine patients, grade 2 diarrhea was seen in one patient, and grade 3 nausea or vomiting was seen in seven patients. There were no treatment-related deaths. CONCLUSION: In the present phase II study, the PIC combination seemed highly active and tolerable in patients with relapsed SCLC when it was administered as second-line treatment. Given the present experience, an evaluation of the PIC regimen as front-line treatment of SCLC is planned.

Single agent gemcitabine in the second-line treatment of advanced non-small cell lung cancer after treatment with taxane + platinum regimens

2007 ◽  
Vol 25 (2) ◽  
pp. 133-136 ◽  
Author(s):  
Ugur Coskun ◽  
Ali Osman Kaya ◽  
Süleyman Buyukberber ◽  
Mustafa Benekli ◽  
Aytug Uner ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Single Agent ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung

Randomized Phase II Trial of Docetaxel/Irinotecan and Gemcitabine/Irinotecan With or Without Celecoxib in the Second-Line Treatment of Non–Small-Cell Lung Cancer

2006 ◽  
Vol 24 (30) ◽  
pp. 4825-4832 ◽  
Author(s):  
Rogerio Lilenbaum ◽  
Mark A. Socinski ◽  
Nasser K. Altorki ◽  
Lowell L. Hart ◽  
Roger S. Keresztes ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
Patient Reported

Purpose Trials combining irinotecan/docetaxel and irinotecan/gemcitabine in second-line treatment of non–small-cell lung cancer (NSCLC) have yielded promising results. Preliminary data suggested that the selective cyclooxygenase -2 inhibitor celecoxib (CBX) might enhance efficacy of chemotherapeutic regimens. This multicenter, phase II, randomized trial investigated efficacy and safety of irinotecan and docetaxel and irinotecan and gemcitabine, with or without CBX, in second-line treatment of NSCLC. Patients and Methods Patients 18 years or older were randomly assigned to receive irinotecan 60 mg/m2 and docetaxel 35 mg/m2, or irinotecan 100 mg/m2 and gemcitabine 1,000 mg/m2, with or without CBX 400 mg twice daily, for four cycles. Primary efficacy end points were median and 1-year survival probabilities. Patient-reported symptoms were assessed by the Lung Cancer Symptoms Scale (LCSS). Results A total of 133 patients were assessable for efficacy and safety. Median survival time was 6.31 months for patients treated with CBX and 8.99 months for those treated with chemotherapy alone. One-year survival rates were 24% and 36% respectively. The overall toxicity rates and LCSS scores were similar between patients treated or not treated with CBX. Four deaths were considered possibly treatment related. Conclusion Survival results for the second-line regimens in this study were similar to results reported for single-agent therapy in this setting. CBX did not appear to enhance efficacy or improve patient-reported symptoms. The addition of high-dose CBX to second-line chemotherapy in NSCLC cannot be recommended.

Phase II trial of prolonged infusion gemcitabine as second line treatment in non-small cell lung cancer

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 7316-7316
Author(s):  
M. B. Kleinman ◽  
I. Stewart ◽  
S. Ratmanskiy ◽  
M. Gayle ◽  
P. Bonomi
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Phase Ii Trial ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung ◽  
Prolonged Infusion

scholarly journals A Phase I/II Study of GTI-2040 Plus Docetaxel as Second-Line Treatment in Advanced Non-small Cell Lung Cancer: A Study of the PMH Phase II Consortium

2009 ◽  
Vol 4 (9) ◽  
pp. 1163-1169 ◽  
Author(s):  
Natasha B. Leighl ◽  
Scott A. Laurie ◽  
Xueyu E. Chen ◽  
Peter Ellis ◽  
Frances A. Shepherd ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung
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