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Lung CancerPhase 2NCT00278187

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

A Phase 2 study testing volociximab and erlotinib hydrochloride in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
volociximab and erlotinib hydrochloride
How many people
Not given
Where
1 siteUnited States
Study dates
Jul 2005to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
volociximab, erlotinib hydrochloride
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • volociximabBiological

  • erlotinib hydrochlorideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with confirmed tumor response

Secondary outcomes (5)
  1. Time to disease progression

  2. Duration of response

  3. Adverse events and serious adverse events

  4. Pharmacokinetics

  5. Immunogenicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2006 (estimated)
  2. Study startJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00278187
Sponsor's protocol ID
CDR0000453542
Other IDs
UCLA-0504066-01, PDL-M200-1206
Status last verified
Feb 2006
First submitted
16 Jan 2006
Last updated
19 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing volociximab and erlotinib hydrochloride in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with confirmed tumor response. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.

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