Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

Phase 2

• Conditions: on-small-cell lung carcinoma

• Registration Number: JPRN-C000000084
• Lead Sponsor: Chiba Lung Cancer Study Group

Brief Summary

Even with the standard first-line chemotherapy, advanced non-small cell lung cancer (NSCLC) recurs in most cases. The purpose of this study is to develop a new chemotherapeutic regimen for patients with NSCLC that has relapsed or was refractory to previous chemotherapy. Patients with proven NSCLC refractory or recurrent after previous single-regimen chemotherapy, PS of 0 to 2, age of 15 years or older, adequate organ functions and measurable lesions were treated with irinotecan at 60 mg/m2 and cisplatin at 25 mg/m2 with 1,000 ml hydration on day 1. This administration, considered as one cycle, was repeated every week without rest unless encountering defined skip and dose-reduction criteria. The treatment was administered for 6 cycles over a 49-day period, both median values, to 48 patients, with a response rate of 26%, progression free and median survival times of 3 and 11 months, respectively, and a 1-year survival rate of 46%. The most frequent grade 3 or 4 toxicities were neutropenia, anaemia and nausea, which were manageable. Subset analyses suggested that the response rate was independent of response to the first-line chemotherapy. In conclusion, second-line chemotherapy of weekly irinotecan and cisplatin with minimum hydration seemed effective, with tolerable toxicity, and is potentially useful irrespective of the outcome of previous chemotherapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-01
• Study Completion: 2006-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

1) Prior chemotherapy including irinotecan 2) Prior chemotherapy by 2 or more chemotherapeutic regimens 3) Prior resection 4) Requirement of thoracic irradiation 5) Any contraindication for irinotecan, such as interstitial pneumonitis 6) Pleural effusion/ascites requiring treatment 7) Pericardial effusion 8) Serious concomitant medical conditions, including uncontrolled diabetes mellitus, angina pectoris, myocardial infarction within 3 months, and others 9) Brain metastasis requiring treatment 10) Concomitant malignancy 11) History of serious drug allergy 12) Pregnancy, potential pregnancy, or breast feeding 13) Others

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate (6 weeks interval for confirming SD)

Secondary Outcome Measures

Name	Time	Method
Toxicity Survival