Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/27/2017
Start Date:June 1, 2007

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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)

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they
work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage
IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work
in different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving more than one drug
(combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as
bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab
also may stop the growth of non-small cell lung cancer by blocking the growth of new blood
vessels necessary for tumor growth. It is not yet known whether chemotherapy is more
effective with or without bevacizumab in treating non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To evaluate overall survival with chemotherapy with or without bevacizumab used in the
adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung
cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To evaluate disease-free survival and toxicity with chemotherapy with or without
bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA
NSCLC.

II. To perform analyses of tissue and blood to establish factors that predict clinical
outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early
stage NSCLC.

III. To determine whether smoking status is linked to outcome for patients with resected
stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the
adjuvant setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy
regimens.

REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days
1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine
ditartrate administration.

REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on
day 1 immediately following docetaxel administration.

REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and
cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration.

REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10
minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium
administration.

In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of
disease progression or unacceptable toxicity.

ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in Arm I.
Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab
repeats every 21 days for up to 1 year.

After completion of study treatment, patients are followed up periodically for 10 years.

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)

- Patients must be 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

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Patients must not 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 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

- Absolute neutrophil count (ANC) >= 1500 mm^3

- Platelets >= 100,000/mm^3

- Prothrombin time/international normalized ratio (INR) =< 1.5

- Or, if patient is on therapeutic anticoagulation, prothrombin time/INR =< 3.0

- 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)

- Urine protein should be screened by urine analysis for urine protein creatinine (UPC)
ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must
be < 1000 mg (1 g) for patient enrollment

- Patients with a known history of myocardial infarction or other evidence of arterial
thrombotic disease (angina) will be allowed on study only if they have had no evidence
of active disease for at least 12 months prior to randomization

- Patients with any history of cerebral vascular accident (CVA) or transient ischemic
attack (TIA) will not be allowed on trial

- Women must not be 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

- Both fertile men and women must agree to use adequate contraceptive measures during
study treatment and for at least 6 months after completion of bevacizumab

- Patients must not have 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 must have no history of bleeding diathesis or coagulopathy

- All patients must have a documented blood pressure (BP) with systolic =< 150 and
diastolic =< 90 within 28 days of registration; patients with known hypertension must
be on a stable regimen of anti-hypertensive therapy

- Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory
agents (NSAIDS) are eligible; treatment with dipyridamole (Persantine), ticlopine
(Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed; patients
must have stopped taking any of these agents at least 7 days prior to randomization

- Patients must not have 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 must not have a history of abdominal fistula, gastrointestinal perforation or
intra-abdominal abscess within 28 days prior to randomization

- Patients must not have any anticipated major surgical procedure(s) during the course
of the study

- Patients must not have known hypersensitivity to Chinese hamster ovary cell products
or other recombinant human antibodies

- Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving
prophylactic anticoagulation of venous access devices, provided that coagulation
studies meet entry criteria above; caution must be exercised for patients requiring
anticoagulation, including treatment with low dose heparin or low molecular weight
heparin for deep vein thrombosis (DVT) prophylaxis while on study

- Patients with ongoing post-operative hemoptysis (defined as bright red blood of 1/2
teaspoon or more) are not eligible; patients with pre-operative hemoptysis that has
resolved post-operatively are eligible

- Patients who will receive pemetrexed (pemetrexed disodium)/cisplatin therapy must also
meet the following criteria:

- Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell
histology

- Calculated creatinine clearance must be obtained within 2 weeks of randomization
and calculated creatinine clearance (CrCl) must be >= 45 mL/min using the
standard Cockcroft and Gault formula, or the measured glomerular filtration rate
(GFR) using the appropriate radiolabeled method ([51]chromium-labeled
ethylenediaminetetraacetic acid [51-CrEDTA] or technetium 99m
diethylenetriamine-pentaacetic acid [Tc99m-DTPA]) must be used to calculate CrCl
We found this trial at
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361 Old Belgrade Road
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2545 Schoenersville Rd
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330 Brookline Ave
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800 Washington St
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