Status:
UNKNOWN
Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as volociximab, 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 * Evaluate the response rate in patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer treated with volociximab and erlotinib hydrochlori...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
- Failed ≥ 1 prior chemotherapy regimen OR refused first-line therapy
- Measurable disease
- No active and untreated CNS tumor or metastasis
- Previously treated CNS tumor(s) allowed if CT scan or MRI shows clear-cut response or resolution of the original lesion(s)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Hemoglobin ≥ 9.0 g/dL
- WBC ≥ 2,500/mm\^3
- Absolute neutrophil count ≥ 1,000/mm\^3 (growth factor independent)
- Platelet count ≥ 100,000/mm\^3
- Total bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if patient has liver metastases)
- Alkaline phosphatase ≤ 5 times ULN
- Serum creatinine ≤ 2.0 mg/dL
- PT/PTT normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective (double barrier or abstinence) contraception
- No uncontrolled seizure disorder or active neurological disease
- No thromboembolic events (i.e., stroke or deep vein thrombosis) within the past year
- No clinically significant medical condition that would complicate compliance with study treatment or be exacerbated by bleeding, including but not limited to:
- Known bleeding disorders, such as coagulation defects and thrombasthenias
- Active gastric or duodenal ulcer
- History of gastrointestinal (GI) bleeding requiring transfusion within the past year
- History of tumor bleeding
- History of significant hemoptysis requiring intervention (i.e., transfusion, laser therapy, surgical treatment, or radiation) within the past year
- No known active infections requiring IV antibiotics, antivirals, or antifungals (e.g., HIV, hepatitis B, or hepatitis C infection)
- No unstable cardiac disease, including any of the following:
- Poorly controlled angina
- Congestive heart failure
- Arrhythmias
- Myocardial infarction within the past year
- Acute ischemia by ECG
- Untreated significant conduction abnormality
- Bifascicular block (defined as left anterior hemiblock in the presence of right bundle branch block)
- Second- or third-degree atrioventricular block
- No asthma or oxygen-dependent chronic pulmonary disease
- No cerebrovascular event (e.g., stroke or transient ischemic attack) within the past year
- No peripheral vascular disease requiring surgery within the past year
- No clinically significant or unstable medical condition, including, but not limited to, any of the following:
- Diabetes mellitus requiring insulin
- Uncontrolled hypertension
- Uncontrolled or symptomatic orthostatic hypertension
- No serious psychiatric illness, active alcoholism, or drug addiction that may preclude study treatment
- No condition that, in the investigator's opinion, would make the patient unsuitable for study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior immunotherapy, including monoclonal antibodies, or vaccine therapy allowed
- No systemic biologic, immunotherapy, or radiation therapy within the past 4 weeks
- Local radiotherapy to a single site of bone metastasis within the past 2 weeks allowed provided patient has recovered from any side effects
- No prior volociximab, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, or inhibitors of α5β1 integrin (antibodies or small molecules)
- No known hypersensitivity to murine proteins or chimeric antibodies or other components of study drugs
- No other investigational drug within the past 4 weeks or 5 half-lives (whichever is longer)
- No monoclonal antibody therapy within the past 4 weeks or 5 half-lives (whichever is longer)
- No major surgery (e.g., thoracotomy) within 4 weeks prior to study entry
- No minor surgery (e.g., central venous line placement) within 1 week prior to study entry
- No sargramostim (GM-CSF) or filgrastim (G-CSF) within the past 7 days
- No prior bone marrow or stem cell transplantation
- No concurrent chronic medications that would interfere with study drug assessment including, but not limited to:
- High-dose glucocorticoids (prednisone ≥ 20 mg/day or equivalent)
- Chronic nonsteroidal anti-inflammatory drugs (NSAIDs)
- Infrequent or as occasion requires use of NSAIDs allowed
- No concurrent high-dose aspirin (\> 81 mg/day), high-dose warfarin, or heparin
- Aspirin ≤ 81 mg/day, low-dose warfarin (1 mg/day), or low-dose heparin for IV-catheter patency allowed
- No concurrent chemotherapy, therapeutic radiation, or anticancer hormonal therapy
- No other concurrent immunotherapy
- No other concurrent potentially antiangiogenic therapy (e.g., cyclo-oxygenase-2 inhibitors, thalidomide, or tretinoin)
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00278187
Start Date
July 1 2005
Last Update
December 19 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781