Imatinib Mesylate and Bevacizumab After First-Line Chemotherapy and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Purpose
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 ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Imatinib mesylate and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate together with bevacizumab as maintenance therapy may stop non-small cell lung cancer from growing or coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: bevacizumab Drug: imatinib mesylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity rate, defined as percentage of patients experiencing a grade 3 or greater adverse event [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the clinical efficacy of maintenance therapy comprising imatinib mesylate and bevacizumab after completion of first-line, platinum-based chemotherapy and bevacizumab, in terms of progression-free survival, in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Assess the safety profile of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate twice daily on days 1-21 and bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
| Study Chair: | Laurie Carr, MD | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
Additional Information:
No publications provided
| Responsible Party: | Laurie Carr, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00425646 History of Changes |
| Other Study ID Numbers: | 6351, UWCC-6351, UWCC-06-3622-H/B, NOVARTIS-UWCC-6351, CDR0000526130 |
| Study First Received: | January 19, 2007 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Washington:
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
bronchoalveolar cell lung cancer large cell lung cancer recurrent non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Imatinib Bevacizumab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013