A Phase II Study Evaluating a Maintenance Strategy of Gleevce® (Imatinib Mesylate) and Bevacizumab in Patients With Advanced, Non-squamous, Non-small Cell Lung Cancer, Following Completion of First-line Chemotherapy With Bevacizumab
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Stage IIIB (by pleural effusion only) or stage IV disease
- No predominately squamous cell carcinoma
- Mixed tumors will be categorized by predominant cell type
- Must have completed 4 courses of platinum-based, doublet chemotherapy and
bevacizumab*, has no disease progression, and meets the following criteria:
- Platinum agent may have included carboplatin or cisplatin
- Second agent may have included paclitaxel, docetaxel, gemcitabine hydrochloride,
vinorelbine ditartrate, or pemetrexed disodium
- A change in the platinum doublet is acceptable provided the following are true:
- Basis for change was toxicity rather than disease progression
- Total number of courses of any platinum doublet plus bevacizumab was 4
- At least 3 of 4 courses must have included bevacizumab NOTE: *Patients age 70
and over may have completed 4 courses of single-agent chemotherapy plus
bevacizumab; single agent chemotherapy may have included paclitaxel, docetaxel,
gemcitabine hydrochloride, vinorelbine ditartrate, or pemetrexed disodium
- No brain metastases by brain MRI or head CT scan
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Bilirubin ≤ 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Absolute neutrophil count ≥ 1500/mm³
- Platelet count ≥ 100,000/mm³
- INR ≤ 1.5 times ULN
- Urine protein:creatinine ratio ≤ 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months
after completion of study treatment
- No history of gross hemoptysis (defined as > ½ teaspoon of bright red blood)
- No inadequately controlled hypertension (defined as blood pressure > 150/100 mm Hg on
antihypertensive medications)
- No significant traumatic injury within the past 28 days
- No condition requiring continuous administration of systemic corticosteroids
- No medical condition that would preclude study treatment
- No medical comorbidities, including any of the following:
- Unstable angina
- Congestive heart failure ≥ grade 2
- Myocardial infarction within the past 6 months
- Stroke within the past 6 months
- Peripheral vascular disease ≥ grade 2 within the past 6 months
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy in the metastatic setting, except for 4 courses of
platinum-based, doublet chemotherapy plus bevacizumab in the first-line setting
- Prior adjuvant, neoadjuvant, or combined modality chemoradiation for localized
non-small cell lung cancer allowed provided ≥ 6 months elapsed before metastatic
recurrence
- At least 28 days since prior major surgical procedure
- No prior antiangiogenic drug, including AMG 706, CP-547, 632, vatalanib, AZD2171,
thalidomide, sorafenib tosylate, or sunitinib malate
- No other concurrent investigational drugs
- No concurrent grapefruit juice or products containing grapefruit
- No other concurrent anticancer agents, including chemotherapy and biological agents
- No concurrent major surgical procedure
- No concurrent therapeutic coagulation comprising warfarin, heparin, or low molecular
weight heparin
- Low-dose warfarin (e.g., 1 mg/day) for prophylaxis of central venous catheter
thrombosis allowed
- No chronic daily acetylsalicylic acid (> 325 mg/day) or other full-dose nonsteroidal
anti-inflammatory drug with antiplatelet activity