Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278187
Recruitment Status : Unknown
Verified February 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2006
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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 carry tumor-killing substances to them. Volociximab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving volociximab together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving volociximab together with erlotinib works in treating patients with stage III or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: volociximab Drug: erlotinib hydrochloride Phase 2

Detailed Description:



  • 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 hydrochloride.


  • Evaluate the time to disease progression and duration of response in patients treated with this regimen.
  • Evaluate the safety of this drug regimen in these patients.
  • Evaluate the pharmacokinetics this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive volociximab IV over 30 minutes once every 2 weeks and oral erlotinib hydrochloride daily for 52 weeks in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open-Label Study of Volociximab (M200) in Combination With Erlotinib (Tarceva™) in Previously Treated Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non-Small Cell Lung Cancer
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of patients with confirmed tumor response

Secondary Outcome Measures :
  1. Time to disease progression
  2. Duration of response
  3. Adverse events and serious adverse events
  4. Pharmacokinetics
  5. Immunogenicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278187

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert A. Figlin, MD, FACP Jonsson Comprehensive Cancer Center Identifier: NCT00278187     History of Changes
Other Study ID Numbers: CDR0000453542
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: February 2006

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs