A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) - IIIA Non- Small Cell Lung Cancer (NSCLC) - E1505

ICORG0 sites1,500 target enrollmentJune 11, 2007

DrugsAvastin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ICORG
Enrollment: 1500
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 11, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ICORG

Eligibility Criteria

Inclusion Criteria

•1\.0 In order to be eligible for this trial, patients must have undergone complete resection of their non\-small cell lung cancer (NSCLC) \[stage IB (\=/\= 4 cm) \- IIIA (T2\-3N0, T1\-3N1, T1\-3N2\) prior to enrollment. (Refer to Appendix X for staging guidelines per AJCC 6th edition). Accepted types of resection will consist of lobectomy, sleeve lobectomy, bi\-lobectomy or pneumonectomy. Resections by segmentectomy or wedge resection will not be accepted. Mediastinal lymph node sampling at specified levels is required pre\-operative (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors). Please refer to Section 5 for specific details on lymph node level sampling requirements and resection criteria.
•2\.0 Patients must be no less than 6 weeks (42 days) and no more (84 days) than 12 weeks post\-thoracotomy at the time of randomization and must be adequately recovered from surgery.
•3\.0 Age \= 18 years.
•4\.0 ECOG performance status 0 or 1\.
•5\.0 Patients must not have received the following:
•5\.1 Prior systemic chemotherapy at any time. Methotrexate (MTX) given in low doses for non\-malignant conditions with last dose at least 2 weeks prior to date of registration will be allowed. Other low dose chemotherapeutics for non\-malignant conditions will be considered, but review by the study chair is required.
•5\.2 Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. (Prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable.)
•6\.0 Patients must not have any history of cancer within 5 years from randomization, with the exception of in\-situ carcinoma of the cervix or completely resected non\-melanoma skin cancer.
•7\.0 Required laboratory values obtained within two weeks of randomization:
•ANC \= 1500 mm3

Exclusion Criteria

•1\.0 Patients less than 6 weeks (42 days) and more than 12 weeks (84 days) post\-thoracotomy at the time of randomization and must be adequately recovered from surgery.
•2\.0 Age \= 18 years.
•3\.0 Patients who have received the following:
•3\.1 Prior systemic chemotherapy at any time. (Please refer to principal inclusion criteria 5\.1 for exception)
•3\.2 Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. (Prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable.)
•4\.0 Patients with history of cancer within 5 years from randomization, with the exception of in\-situ carcinoma of the cervix or completely resected non\-melanoma skin cancer.
•5\.0 Required laboratory values not obtained within two weeks of randomization
•6\.0 Inadequate renal function.
•7\.0 Evidence of active myocardial infarction or other evidence of arterial thrombotic disease (angina) within 12 months prior to randomization.
•8\.0 History of cerebral vascular accident (CVA) or transient ischemic attack (TIA).