Status:
COMPLETED
Imatinib Mesylate and Bevacizumab After First-Line Chemotherapy and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ...
Detailed Description
OBJECTIVES: Primary * Determine the clinical efficacy of maintenance therapy comprising imatinib mesylate and bevacizumab after completion of first-line, platinum-based chemotherapy and bevacizumab,...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00425646
Start Date
November 1 2006
End Date
July 1 2009
Last Update
May 6 2013
Active Locations (1)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023