Lung CancerPhase 2NCT00541099
Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing bevacizumab and docetaxel in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 3 sites in United States.
Trial summary
RATIONALE: 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. Read more about this study
- Who is it for?
- Ages 75 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bevacizumab and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2008to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically confirmed non-small cell lung cancer
- Stage III or IV disease
- Stage III disease allowed, provided the patient is not a candidate for concurrent chemotherapy and radiotherapy
- Mixed histology allowed, provided the biopsy has less than 50% squamous cell histology
- Measurable or evaluable disease
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
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- Life expectancy > 12 weeks
- Leukocytes ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (< 5 times ULN if patients has liver metastases)
- Creatinine ≤ 1.5 times normal
- Left ventricular function ≥ normal by MUGA scan or ECHO
- Urine protein:creatinine ratio ≤ 1.0 AND/OR urine protein ≤ 1+ by dipstick analysis OR protein ≤ 1 g/24-hour urine collection
- Fertile patients must use effective contraception and women should avoid breastfeeding
Who cannot join
- Squamous cell histology
- Evidence of cavitation in the tumor
- Tumors in close proximity to major blood vessels
- No active, untreated brain metastases
- More than 7 days since prior treatment for brain metastases AND no evidence of hemorrhage in the lesion
- Stable or declining dose of steroids allowed
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- PATIENT CHARACTERISTICS:
- Resting blood pressure (BP) consistently > 140/90 mm Hg
- Patients whose BP is controlled (≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic) after adjusting, starting, or increasing the medications are eligible
- Significant hemorrhage (i.e., > 30 mL bleeding/episode ) or hemoptysis (i.e., > 5 mL fresh blood in one episode) in the previous 3 months
- Evidence of bleeding diathesis or coagulopathy
- Significant traumatic injury within the past 28 days
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- History of other active malignancies
- If patient has other cancers such as PSA only (without clinical or radiographic evidence) prostate cancer, the patient can still be considered for this protocol if, in the clinical judgment of the treating physician, NSCLC is the most important malignancy and the other malignancy will not impact patient's overall survival
- Myocardial infarction or cerebrovascular episode within the past year
- Serious nonhealing wound or ulcer
- Significant vascular disease such as aortic aneurysm, aortic dissection, or symptomatic peripheral vascular disease
- Uncontrolled concurrent illness that would limit compliance with study requirements including, but not limited to, the following:
- Ongoing or active infection
- New York Heart Association class II-IV congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations
- Known hypersensitivity to any component of bevacizumab
- PRIOR CONCURRENT THERAPY:
- More than 7 days since prior radiotherapy and recovered
- No concurrent full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular-weight heparin)
- More than 10 days since prior and no concurrent aspirin ≥ 325 mg/day or chronic use of nonsteroidal anti-inflammatory drugs
- More than 28 days since prior and no concurrent major surgical procedure or open biopsy
- More than 7 days since prior core biopsy or other minor procedure, excluding placement of a vascular access device
- No other concurrent investigational agents, commercial agents, or therapies
- More than 30 days since prior participation in a trial involving an investigational agent
- No prior chemotherapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Nevada Cancer Institute
Las Vegas, Nevada, 89135
About this study
Official title: Evaluation of Bevacizumab and Weekly Docetaxel in Elderly (≥ 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV non-small cell lung cancer surviving for at least 6 months when treated with a combination of bevacizumab and weekly docetaxel.
Secondary
- To assess the progression-free and overall survival of patients treated with this regimen.
- To determine the response rate in patients treated with this regimen.
- To assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days 1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab, docetaxel
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV 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.
bevacizumabBiological
Also called Avastin
Avastin 10.0 mg/kg on days 1 and 15
docetaxelDrug
Also called TAXOTERE®
Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
| Study group | Role | What they receive |
|---|---|---|
| Avastin & Docetaxel | Experimental | Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15 Receives: Biological: bevacizumab; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 6 months when treated with combination of Avastin and weekly docetaxel
Secondary outcomes (4)
Progression-free Survival
Progression-free survival in months via the Kaplan-Meier method
Measured: 6 months when treated with combination of Avastin and weekly docetaxel
Overall Survival
Overall survival using Kaplan-Meier method.
Measured: 4 weeks after removal from study or until death
Response Rate
Measured: Every 8 weeks
Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: 1st and 2nd week of each 21 day cycle, up to six cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute
- Investigators
- Shirish M. Gadgeel, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541099
- Sponsor's protocol ID
- CDR0000555019
- Other IDs
- P30CA022453, WSU-2007-053
- Status last verified
- Aug 2014
- First submitted
- 5 Oct 2007
- Last updated
- 27 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bevacizumab and Weekly Docetaxel in Elderly (≥ 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00541099
- Acronym / sponsor ID
- CDR0000555019
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Posted 21 Aug 2014
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 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV non-small cell lung cancer surviving for at least 6 months when treated with a combination of bevacizumab and weekly docetaxel.
Secondary
- To assess the progression-free and overall survival of patients treated with this regimen.
- To determine the response rate in patients treated with this regimen.
- To assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days 1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin & Docetaxel | Experimental | Biological: bevacizumab, Drug: docetaxelAvastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15 |
Who may qualify
- Ages
- 75 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed non-small cell lung cancer
- Measurable or evaluable disease
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- Leukocytes ≥ 3,000/μL
Key exclusion criteria (34 listed)
- Squamous cell histology
- Evidence of cavitation in the tumor
- Tumors in close proximity to major blood vessels
- No active, untreated brain metastases
- Resting blood pressure (BP) consistently > 140/90 mm Hg
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 |
|---|---|---|
| bevacizumabAlso: AvastinAvastin 10.0 mg/kg on days 1 and 15 | Biological | Avastin & Docetaxel |
| docetaxelAlso: TAXOTERE®Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15 | Drug | Avastin & Docetaxel |
Primary outcome
Survival
Time frame: 6 months when treated with combination of Avastin and weekly docetaxel
4 secondary outcomes
Progression-free Survival
Time frame: 6 months when treated with combination of Avastin and weekly docetaxel
Overall Survival
Time frame: 4 weeks after removal from study or until death
Response Rate
Time frame: Every 8 weeks
Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: 1st and 2nd week of each 21 day cycle, up to six cycles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Shirish M. Gadgeel, MD principal investigator
Barbara Ann Karmanos Cancer Institute
3 sites 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 docetaxel in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 3 sites 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?
The sponsor lists 16 inclusion and 34 exclusion criteria. 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 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 21 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival (time frame: 6 months when treated with combination of Avastin and weekly docetaxel). 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 27 Mar 2019.