PER-155-08
Completed
未知
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
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 sites0 target enrollmentJuly 31, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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; 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\-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Absolute neutrophil count (ANC) \>\= 1500 mm^3
- •Platelets \>\= 100,000/mm^3
- •Prothrombin time/international normalized ratio (INR) \=\< 1\.5
- •Partial thromboplastin time (PTT) \=\< institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be \=\< 1\.5 x ULN
- •Total bilirubin \=\< 1\.5 mg/dL
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST]) \< 5 x upper limit of normal (ULN)
- •Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT]) \< 5 x upper limit of normal (ULN)
- •Serum creatinine \=\< 1\.5 x institutional upper limit of normal (ULN)
Exclusion Criteria
- •Patients with no less than 6 weeks (42 days) and no more than 12 weeks (84 days) post\-thoracotomy at the time of randomization and must be adequately recovered from surgery
- •Patients that have received the following: 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. 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)
- •Patients with 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
- •Women pregnant or breast\-feeding. All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy
- •Patients with any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with history of bleeding diathesis or coagulopathy
- •Patients with serious non\-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization OR core biopsy within 7 days prior to randomization
- •Patients with history of abdominal fistula, gastrointestinal perforation or intra\-abdominal abscess within 28 days prior to randomization
- •Patients with anticipated major surgical procedure(s) during the course of the study
- •Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
Outcomes
Primary Outcomes
Not specified
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