Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer

Completed · Phase 2/Phase 3

Conditions studied: Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance

Key facts

Study ID: NCT00021060
Run by: National Cancer Institute (NCI)
People needed: 842
Starts: 2002-08-01
Last updated by the study team: 2013-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma; mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible; cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy
Patients must have advanced NSCLC (stage IIIB with malignant pleural effusion or stage IV or recurrent disease)
Patients must have measurable or non-measurable disease
ECOG performance status 0 or 1
Patients must not have known central nervous system (CNS) metastases; a head CT is required within 4 weeks prior to study entry; (MRIs are also acceptable)
Patients must not have received prior systemic chemotherapy at any time
ANC >= 1500/mm\^3
Platelets >= 100,000/mm\^3
Total bilirubin =< 1.5 mg/dl
Transaminases =< 5 x ULN
Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)
Urine dipstick for proteinuria of less than 1+ (i.e., either 0 or trace); if urine dipstick is >= 1+ then a 24 hour urine for protein must demonstrate < 500 mg of protein in 24 hours to allow participation in the study; note: urinalysis is also acceptable
Patients must have INR =< 1.5 and a PTT no greater than upper limits of normal within 1 week prior to randomization
Pregnant and lactating women are excluded from the study
Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study
Patients must not have had immuno, hormonal or radiation therapy within 3 weeks prior to entering the study; those who have not recovered from adverse events due to agents administered more than 3 weeks earlier are ineligible
Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients must have no history of thrombotic or hemorrhagic disorders
Patients with history of hypertension must be well-controlled (< 150/100) on a stable regimen of anti-hypertensive therapy
Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is also not allowed
Patients must not have serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 21 days prior to starting treatment
Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation of venous access devices is allowed; caution should be taken on treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding
Patients with a history of gross hemoptysis (defined as bright red blood of a 1/2 teaspoon or more) will be excluded from this trial

Where it is running

Eastern Cooperative Oncology Group — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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