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

December 18, 2013 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 hydrochloride.

Secondary

  • 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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients with confirmed tumor response

Secondary Outcome Measures

Outcome Measure
Time to disease progression
Duration of response
Pharmacokinetics
Immunogenicity
Adverse events and serious adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000453542
  • UCLA-0504066-01
  • PDL-M200-1206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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