A Phase II Study of Neo-Adjuvant Gemcitabine, Cisplatin and Bevacizumab in Stage IIIA (N2) Non-Squamous Cell Non-Small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: NSCLC, Stage IIIA (N2)

In brief

Background: * Surgical resection is the treatment of choice for patients with lung cancer, and cure after resection generally depends on whether lymph nodes are involved. A patient with Stage IIIA (N2) lung cancer has cancer in the lymph nodes involving the center of the chest (mediastinum). * Studies have shown that surgery alone as a treatment for Stage IIIA (N2) lung cancer is not as effective as chemotherapy followed by surgery. * Giving chemotherapy upfront may prevent the spread of Stage IIIA (N2) lung cancer tumors, and may shrink the tumors to allow adequate surgery to be performed. It is also thought that chemotherapy is usually better tolerated before major surgery than after, so higher doses can be given. Objectives: * To determine the effectiveness of the combination of three anti-cancer drugs (gemcitabine, cisplatin, and bevacizumab) given before surgery. * To find out what effects this drug combination may have on the patient and the cancer. * To determine if the combination of all three drugs given prior to surgery is more effective and as safe, safer, or less safe than other drug combinations given before surgery. Eligibility: * Patients with Stage IIIA (N2) lung cancer who have not had chemotherapy, radiation, or surgery to treat the cancer. Design: * Evaluations before the treatment period to determine eligibility: * Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. * Tests to evaluate heart and lung function, such as an echocardiogram. * Blood and urine tests. * Disease evaluation with computed tomography (CT), chest X-ray, positron emission tomography (PET) scans, and bronchoscopy/mediastinoscopy (examinations of the inside of the chest and lungs). * Treatment with intravenous gemcitabine, cisplatin, and bevacizumab for three 21-day cycles. * Cycles 1 and 2 - Gemcitabine on day 1 and day 8, cisplatin on day 1, bevacizumab on day 1. * Cycle 3 - Gemcitabine on day 1 and day 8, cisplatin on day 1 (no bevacizumab). * Physical examinations and tests will be conducted throughout each cycle. * Surgery will take place 4 to 6 weeks after the last cycle if heart and lung functions are satisfactory and if the cancer remains stable. * Chemotherapy (four 21-day cycles of cisplatin and etoposide treatments), further evaluations and examinations, and followup studies will take place 4 to 8 weeks after the surgery.

Key facts

Study ID: NCT00924209
Run by: National Cancer Institute (NCI)
People needed: 7
Starts: 2009-03-01
Expected to finish: 2011-09-01
Last updated by the study team: 2018-11-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Squamous cell cancer or mixed tumors with small cell elements.
Tumor of any histology in close proximity to a major vessel or cavitation. (Any tumor abutting an interlobar, main pulmonary artery, vena cava or major vein will be excluded).
History of hemoptysis (bright red blood of one-half teaspoon or more [greater than or equal to 2.5 mL] unrelated to any diagnostic procedure. (Patients who have a history of hemoptysis that occurred greater than 3 months prior to study entry and that is assessed not to be related to tumor may be eligible).
Patients with metastatic disease.
History of uncontrolled or labile hypertension, defined as blood pressure greater than 150/100mmHg (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.3.0 grade greater than or equal to 2), systolic blood pressure greater than 180 mm Hg if diastolic blood pressure less than 90 mm Hg, or diastolic blood pressure greater than 90 mm Hg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment. Patients who have medication controlled hypertension are eligible for the study.
Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris or uncontrolled angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant peripheral vascular disease (Grade II or greater).
Psychiatric or neurologic illness that would limit compliance with study requirements.
Patients with serious illness or medical condition.
Active infection within 14 days before beginning treatment.
Patients may not be receiving any other investigational agents.
History of a malignancy in the last five years other than in situ carcinoma of the cervix, or non-melanomatous skin cancers.
Patients must not be on therapeutic anticoagulation or chronic daily treatment with aspirin 325mg/day within 10 days prior to day 1 on study. Prophylactic anticoagulation during perioperative period is acceptable. Full dose aspirin post surgical resection is acceptable. Low dose aspirin 81mg/day and anticoagulation for line protection are allowed in the perioperative period and the adjuvant setting.
Women who are breast feeding.
History of stroke or transient ischemic attack within 6 months.
History of pulmonary embolism, deep venous thrombosis or other thrombo-embolic event within 6 months prior to study.
Patients with a history of severe hypersensitivity reaction to compounds of similar chemical or biologic composition to cisplatin, gemcitabine, bevacizumab, etoposide or other agents used in the study.
History of a major surgical procedure, open biopsy, or a significant traumatic injury within 35 days prior to commencing treatment, or the anticipation of the need for a major surgical procedure during the course of the study prior to the predetermined date of tumor excision. Fine needle aspirations, core biopsies or mediastinoscopies within 7 days prior to commencing treatment.
History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or tracheo-esophageal fistula.
Non-healing wound or ulcer
Evidence of coagulopathic disorder or hemorrhagic diathesis. International normalized ratio (INR) greater than 1.5.
Patients with existing ototoxicity.
Pregnancy (positive pregnancy test).
Urine protein: creatinine ratio greater than or equal to 1.0 at screening.
Patients known to be human immunodeficiency virus (HIV)-positive or have active hepatitis B/C (due to possible interaction between chemotherapy and highly active antiretroviral therapy (HAART) and antiviral medications used for treatment of active hepatitis B/C).
Serious illness that may preclude adherence to the protocol.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
University Hospital for Lung Diseases — Zagreb, Croatia

Full record on ClinicalTrials.gov

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