Status:
COMPLETED
Bevacizumab and Erlotinib Followed by Cisplatin or Carboplatin and Gemcitabine in Treating Patients With Newly Diagnosed or Recurrent Stage IIIB or Stage IV NSCLC
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: 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...
Detailed Description
OBJECTIVES: Primary * Assess the efficacy of bevacizumab and erlotinib hydrochloride as initial therapy in patients with newly diagnosed or recurrent stage IIIB or IV non-squamous non-small cell lun...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
- Newly diagnosed or recurrent disease
- Meets 1 of the following staging criteria:
- Stage IIIB disease, meeting both of the following criteria:
- Proven malignant effusion or supraclavicular node involvement (i.e., N3 supraclavicular nodes)
- Not a candidate for curative multimodality treatment or surgery
- Stage IV disease
- Measurable disease, defined as ≥ 1 lesion (outside of irradiated areas) that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI
- Immediate chemotherapy not clinically mandatory in the judgement of the investigator
- No intrathoracic large, centrally located tumors and/or cavitary lesions invading or abutting major blood vessels
- No evidence of clinically active interstitial lung disease
- Patients with chronic stable radiographic changes who are asymptomatic are eligible
- No small cell lung cancer (SCLC), squamous NSCLC, or combined SCLC-NSCLC tumors
- No brain metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Hemoglobin ≥ 10 g/dL
- Absolute neutrophil count ≥ 1,500/mm³
- Thrombocyte count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)
- Quick ≥ 70% OR INR ≤ 1.5
- Creatinine ≤ 2.0 times ULN
- Proteinuria ≤ 2+ by urine dipstick
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- Able to understand trial information given by the investigator and complete quality of life questionnaire
- No pre-existing condition that would preclude swallowing and/or absorption of oral medication
- No prior or concurrent malignancies, except for the following:
- Malignancy for which the minimum relapse-free interval is ≥ 5 years
- Nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- No other medical condition that would preclude study participation, including any of the following:
- Unstable or uncompensated respiratory, cardiac, hepatic, or renal disease
- Active infection
- Uncontrolled diabetes mellitus
- Hypertension ≥ 150/100 mm Hg despite treatment
- Myocardial infarction within the past 3 months
- History of hemorrhagic disorders
- Non-healing wound, ulcer, or bone fracture
- No clinical history of coagulopathy or thrombosis
- No hemoptysis or hematemesis ≥ grade 2 (defined as bright red blood of ≥ 5 mL per episode) within the past 6 months
- No known hypersensitivity to study drug(s) or to any other component of the study drugs
- No significant traumatic injury within the past 28 days
- No serious underlying medical condition that would impair the ability of the patient to participate in the trial or that would preclude use of study drugs
- No cerebrovascular accident or other CNS bleeding within the past 6 months
- PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to lesion(s) selected for measurement
- No prior chemotherapy for advanced disease
- At least 6 months since prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC
- Prior intrapleural or intrapericardial local chemotherapy allowed
- No prior endothelial growth factor and/or vascular endothelial growth factor (receptor)-targeted therapy for NSCLC
- More than 28 days since prior major surgical procedure or open biopsy
- More than 30 days since prior treatment in another clinical trial
- No concurrent anticoagulants (e.g., phenprocoumon, acenocoumarol, or full-dose warfarin or heparin)
- No concurrent full-dose continuous use of non-steroid anti-inflammatory drugs (NSAIDs)
- No concurrent aspirin or clopidogrel bisulfate
- Low-dose aspirin (≤ 325 mg daily) may be continued in patients at high risk for arterial thromboembolic disease
- No other concurrent drugs contraindicated for use with the study drugs, according to the Swissmedic-approved product information
- No other concurrent experimental drugs or anticancer therapy, including chemotherapy, immunotherapy, or hormone therapy
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00354549
Start Date
January 1 2006
End Date
September 1 2010
Last Update
May 15 2019
Active Locations (2)
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1
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
2
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500