Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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



- 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


- 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

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.

Inclusion Criteria


- 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

- 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

- 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

- 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

- No monoclonal antibody therapy within the past 4 weeks or 5 half-lives (whichever is

- 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

- 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)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with confirmed tumor response

Safety Issue:


Principal Investigator

Robert A. Figlin, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781