Status:
COMPLETED
S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib 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. So...
Detailed Description
OBJECTIVES: Primary * Assess overall survival of patients with stage IIIB or IV primary non-small cell lung adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and beva...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Adenocarcinoma
- No component of squamous cell carcinoma present
- Incompletely resected or unresectable disease
- Stage IIIB or IV disease as defined below:
- Selected stage IIIB disease
- T4 (cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor)
- Any N
- M0
- Stage IV disease
- Any T
- Any N
- M1 (distant metastases present)
- Recurrent lung cancer in a separate lobe after resection or radiotherapy within the past 5 years OR multifocal lesions in \> 1 lobe considered stage IV disease
- New lesions occurring ≥ 5 years after resection may be considered a separate primary cancer and are not allowed if this is the only focus of lung cancer
- Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI
- Disease must be present outside a previous radiotherapy field OR a new lesion must be inside the port
- Measurable disease must be assessed within the past 28 days
- Nonmeasurable disease must be assessed within the past 42 days
- Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
- Must be a lifelong nonsmoker (\< 100 cigarettes in lifetime)
- Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Total bilirubin normal
- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
- Urine protein:creatinine ratio ≤ 0.5 OR urine protein \< 1,000 mg by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Hypertension allowed if controlled on medication prior to study enrollment
- Must be willing to provide prior smoking history
- No immediate life-threatening complications from malignancies
- No prior major medical condition, psychological condition, or social situation that would preclude study treatment
- No hemoptysis ≥ ½ teaspoon within the past 28 days
- No clinical history of pulmonary or upper respiratory hemorrhage ≥ grade 2 within the past 6 months or grade 1 within the past 28 days
- No history of either thrombosis or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
- No serious nonhealing wound, ulcer, or bone fracture
- No other prior malignancy except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Adequately treated stage I or II cancer from which the patient is currently in complete remission
- In situ cervical cancer
- Any other cancer from which the patient has been disease-free for 5 years
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 7 days since prior fine-needle aspiration or core biopsy
- At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and recovered
- At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and recovered
- At least 28 days since prior systemic chemotherapy
- Prior biologic therapy allowed
- No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies against the epidermal growth factor receptor or vascular endothelial growth factor axes
- Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation
- No concurrent surgery
- No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy, biological therapy, or radiotherapy) directed at this cancer
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00445848
Start Date
July 1 2007
End Date
January 1 2014
Last Update
March 5 2020
Active Locations (153)
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1
Kaiser Permanente - Deer Valley
Antioch, California, United States, 94531
2
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
3
Peninsula Medical Center
Burlingame, California, United States, 94010
4
Kaiser Permanente - Fremont
Fremont, California, United States, 94538