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.
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
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.
Proportion of patients with confirmed tumor response
Secondary outcomes (5)
Time to disease progression
Duration of response
Adverse events and serious adverse events
Pharmacokinetics
Immunogenicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert A. Figlin, MD, FACP, Study chair, Jonsson Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00278187
- Acronym / sponsor ID
- CDR0000453542
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volociximab | Biological | – |
| erlotinib hydrochloride | Drug | – |
Primary outcome
Proportion of patients with confirmed tumor response
5 secondary outcomes
Time to disease progression
Duration of response
Adverse events and serious adverse events
Pharmacokinetics
Immunogenicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A. Figlin, MD, FACP study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
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.