Lung CancerPhase 2NCT00425646
Imatinib Mesylate and Bevacizumab After First-Line Chemotherapy and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing bevacizumab and imatinib mesylate in people with Lung Cancer, run by University of Washington at 1 site in United States.
Trial summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. 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?
- bevacizumab and imatinib mesylate
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jul 2009
- 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 non-small cell lung cancer
- Stage IIIB (by pleural effusion only) or stage IV disease
- No predominately squamous cell carcinoma
- Mixed tumors will be categorized by predominant cell type
- Must have completed 4 courses of platinum-based, doublet chemotherapy and bevacizumab*, has no disease progression, and meets the following criteria:
- Platinum agent may have included carboplatin or cisplatin
- Second agent may have included paclitaxel, docetaxel, gemcitabine hydrochloride, vinorelbine ditartrate, or pemetrexed disodium
- A change in the platinum doublet is acceptable provided the following are true:
- Basis for change was toxicity rather than disease progression
- Total number of courses of any platinum doublet plus bevacizumab was 4
- At least 3 of 4 courses must have included bevacizumab NOTE: *Patients age 70 and over may have completed 4 courses of single-agent chemotherapy plus bevacizumab; single agent chemotherapy may have included paclitaxel, docetaxel, gemcitabine hydrochloride, vinorelbine ditartrate, or pemetrexed disodium
- No brain metastases by brain MRI or head CT scan
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Bilirubin ≤ 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Absolute neutrophil count ≥ 1500/mm³
- Platelet count ≥ 100,000/mm³
- INR ≤ 1.5 times ULN
- Urine protein:creatinine ratio ≤ 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- No history of gross hemoptysis (defined as > ½ teaspoon of bright red blood)
- No inadequately controlled hypertension (defined as blood pressure > 150/100 mm Hg on antihypertensive medications)
- No significant traumatic injury within the past 28 days
- No condition requiring continuous administration of systemic corticosteroids
- No medical condition that would preclude study treatment
- No medical comorbidities, including any of the following:
- Unstable angina
- Congestive heart failure ≥ grade 2
- Myocardial infarction within the past 6 months
- Stroke within the past 6 months
- Peripheral vascular disease ≥ grade 2 within the past 6 months
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy in the metastatic setting, except for 4 courses of platinum-based, doublet chemotherapy plus bevacizumab in the first-line setting
- Prior adjuvant, neoadjuvant, or combined modality chemoradiation for localized non-small cell lung cancer allowed provided ≥ 6 months elapsed before metastatic recurrence
- At least 28 days since prior major surgical procedure
- No prior antiangiogenic drug, including AMG 706, CP-547, 632, vatalanib, AZD2171, thalidomide, sorafenib tosylate, or sunitinib malate
- No other concurrent investigational drugs
- No concurrent grapefruit juice or products containing grapefruit
- No other concurrent anticancer agents, including chemotherapy and biological agents
- No concurrent major surgical procedure
- No concurrent therapeutic coagulation comprising warfarin, heparin, or low molecular weight heparin
- Low-dose warfarin (e.g., 1 mg/day) for prophylaxis of central venous catheter thrombosis allowed
- No chronic daily acetylsalicylic acid (> 325 mg/day) or other full-dose nonsteroidal anti-inflammatory drug with antiplatelet activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: A Phase II Study Evaluating a Maintenance Strategy of Gleevce® (Imatinib Mesylate) and Bevacizumab in Patients With Advanced, Non-squamous, Non-small Cell Lung Cancer, Following Completion of First-line Chemotherapy With Bevacizumab
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, 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. Imatinib mesylate and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate together with bevacizumab as maintenance therapy may stop non-small cell lung cancer from growing or coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the clinical efficacy of maintenance therapy comprising imatinib mesylate and bevacizumab after completion of first-line, platinum-based chemotherapy and bevacizumab, in terms of progression-free survival, in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Assess the safety profile of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate twice daily on days 1-21 and bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab, imatinib mesylate
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
imatinib mesylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Secondary outcomes (2)
Overall survival
Toxicity rate, defined as percentage of patients experiencing a grade 3 or greater adverse event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionOct 2007
- Study completionJul 2009
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 University of WashingtonThe 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Laurie Carr, MD, Study chair, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425646
- Sponsor's protocol ID
- 6351
- Other IDs
- UWCC-6351, UWCC-06-3622-H/B, NOVARTIS-UWCC-6351, CDR0000526130
- Status last verified
- May 2013
- First submitted
- 19 Jan 2007
- Last updated
- 6 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating a Maintenance Strategy of Gleevce® (Imatinib Mesylate) and Bevacizumab in Patients With Advanced, Non-squamous, Non-small Cell Lung Cancer, Following Completion of First-line Chemotherapy With Bevacizumab
- ClinicalTrials.gov ID
- NCT00425646
- Acronym / sponsor ID
- 6351
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jan 2007 (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: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, 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. Imatinib mesylate and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate together with bevacizumab as maintenance therapy may stop non-small cell lung cancer from growing or coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the clinical efficacy of maintenance therapy comprising imatinib mesylate and bevacizumab after completion of first-line, platinum-based chemotherapy and bevacizumab, in terms of progression-free survival, in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Assess the safety profile of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate twice daily on days 1-21 and bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 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 |
|---|---|---|
| bevacizumab | Biological | – |
| imatinib mesylate | Drug | – |
Primary outcome
Progression-free survival
2 secondary outcomes
Overall survival
Toxicity rate, defined as percentage of patients experiencing a grade 3 or greater adverse event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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.
Laurie Carr, MD study chair
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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 bevacizumab and imatinib mesylate in people with Lung Cancer, run by University of Washington 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: finished, as of the sponsor's last update on 6 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival. 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 6 May 2013.