Phase II trial of gefitinib plus pemetrexed after the relapse to gefitinib in the patients with non-small-cell lung cancer harboring EGFR gene mutations. - Phase II trial of gefitinib plus pemetrexed after the relapse to gefitinib in the patients with non-small-cell lung cancer harboring EGFR gene mutations.

Hanshin-Saga Collaborative Cancer Study Group0 sites45 target enrollmentMay 13, 2013

ConditionsSCLC

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: SCLC
Sponsor: Hanshin-Saga Collaborative Cancer Study Group
Enrollment: 45
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 13, 2013

End Date

March 31, 2017

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hanshin-Saga Collaborative Cancer Study Group

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Prior chemotherapy or other systemic anti\-cancer treatment (excluding EGFR TKIs). 2\. Not considered to require radiotherapy to the lung at the time of study entry or in the near future. 3\. Patients with past history of acute lung disorder or interstitial pneumonia, drug\-induced interstitial disease or radiation pneumonitis requiring steroid therapy. Or those presenting the signs of comorbidity of acute disorder or interstitial pneumonia, or those having clear interstitial pneumonia or pulmonary fibrosis on chest CT. 4\. Patients with large amount of or uncontrollable pleural effusion/ascites/pericardial fluid. 5\. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy. 6\. Patients with past history of serious drug allergy. 7\. Concomitant use of CYP3A4 inducers eg phenytoin, carbamazepine, rifampicin, barbiturates or St John's Wort. 8\. Patients with serious infectious disease or other serious complications. 9\. As judged by the investigator, any evidence of severe or uncontrolled systemic disease. 10\. Patients with complication by poorly controllable diabetes mellitus. 11\. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication. 12\. Patients with active double cancer. Or those who have been diagnosed as having malignant tumor within the past 5 years. 13\. Patients with clinically problematic mental disorder, etc. 14\. Patients who are pregnant, lactating or may be pregnant, or those who have no intention of contraception. 15\. Treatment with a non\-approved or investigational drug within 30 days before Day 1 of study treatment. 16\. Patients who are involved in the planning and practice of this study. 17\. Previous enrolment or treatment in the present study. 18\. Other patients who have been judged by attending physicians, etc. as being inappropriate for safe conduction of this study.