Lung CancerPhase 2NCT00293332
Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery
A Phase 2 study testing bevacizumab, carboplatin and docetaxel in people with Lung Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. 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, carboplatin and docetaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Apr 2007
- 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 confirmed non-small cell lung cancer
- No squamous cell carcinoma
- No histology in close proximity to a major vessel
- Resectable stage IB-IIIA disease
- No CNS or brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
- Bilirubin normal
- Creatinine ≤ 1.5 mg/dL
- Urine protein:creatinine < 1.0
- Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:
- AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST and ALT normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
- Adequate pulmonary and cardiovascular function to tolerate surgical resection
- No cavitation or history of hemoptysis (i.e., bright red blood ≥ ½ teaspoon)
- No existing peripheral neuropathy ≥ grade 1
- No known history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- No history of serious systemic disease, including any of the following:
- Myocardial infarction within the past 6 months
- Uncontrolled hypertension (i.e., blood pressure > 150/110 mm Hg on medication)
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Unstable symptomatic arrhythmia requiring medication
- Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
- Clinically significant peripheral vascular disease (i.e., grade II or higher)
- No history of significant neurological or psychiatric condition
- No known active infection within the past 14 days
- No serious, nonhealing wound, ulcer, or bone fracture
- No evidence of bleeding diathesis or coagulopathy
- No stroke within the past 6 months
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No other serious illness or medical condition
- No active infection
- No other currently active malignancy except nonmelanoma skin cancer
- Malignancies for which therapy has been completed and are considered to have ≤ 30% chance of risk of relapse are not considered active
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or VEGF inhibitor
- No prior (i.e., within the past 4 weeks), concurrent, or anticipated participation in another experimental drug study except a Genentech-sponsored bevacizumab cancer study
- No major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days
- No anticipation for major surgical procedure during study treatment
- No fine-needle aspiration or core biopsy within 7 days prior to study entry
- No concurrent full-dose anticoagulation
- No other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy for this cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.
Secondary
- Determine the median and overall survival of patients treated with this regimen.
- Determine the safety profile of this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the pathologic response rate and the resectability rate in patients treated with this regimen.
- Correlate vascular endothelial growth factor (VEGF) levels or expression with response and survival of patients treated with this regimen.
OUTLINE: Patients receive docetaxel IV over 15-60 minutes, carboplatin IV over 30-60 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after completion of chemotherapy, eligible patients with no distant or mediastinal disease progression undergo lobectomy, pneumonectomy, or segmentectomy with standard radical mediastinal lymph node dissection.
NOTE: *Bevacizumab is only administered during courses 1 and 2.
After completion of study treatment, patients are followed periodically for 8 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab, carboplatin, docetaxel, conventional surgery
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA 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
Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.
carboplatinDrug
Also called Paraplatin
Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.
docetaxelDrug
Also called Taxotere
Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.
conventional surgeryProcedure or surgery
Also called Resection
Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate by CT scan after 3 courses of induction treatment
Measured: After 3 cycles of induction treatment
Secondary outcomes (10)
Pathologic response rate after 3 courses of induction treatment
Measured: After 3 cycles of induction treatment
Resectability rate after 3 courses of induction treatment
Measured: After 3 cycles of induction treatment
Median survival at 2 years after surgery
Measured: 2 years after surgery
Safety after 3 courses of induction treatment
Measured: After 3 cycles of induction treatment
Overall survival at 2 years after surgery
Measured: 2 years after surgery
Time to treatment failure within 2 years after surgery
Measured: 2 years after surgery
Correlation of serum VEGF levels prior to neoadjuvant therapy with primary and secondary objectives prior to start of induction treatment
Measured: Before induction treatment
Correlation of serum VEGF expression in resected tumor with primary and secondary objectives
Measured: After surgical removal of tumor
Correlation of VEGF levels measured immediately after resection and after adjuvant bevacizumab therapy with primary and secondary objectives
Measured: After resection and after adjuvant bevacizumab
Assay additional downstream VEGF activation pathway markers
Measured: At any time during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionMar 2007
- Study completionApr 2007
Why it stopped: Terminated due to low subject accrual
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 California, San FranciscoThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Sarita Dubey, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293332
- Sponsor's protocol ID
- CDR0000455640
- Other IDs
- UCSF-04652, UCSF-IIT-12198, UCSF-H5535-25047-01A
- Status last verified
- Jun 2007
- First submitted
- 16 Feb 2006
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00293332
- Acronym / sponsor ID
- CDR0000455640
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low subject accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 17 Feb 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: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.
Secondary
- Determine the median and overall survival of patients treated with this regimen.
- Determine the safety profile of this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the pathologic response rate and the resectability rate in patients treated with this regimen.
- Correlate vascular endothelial growth factor (VEGF) levels or expression with response and survival of patients treated with this regimen.
OUTLINE: Patients receive docetaxel IV over 15-60 minutes, carboplatin IV over 30-60 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after completion of chemotherapy, eligible patients with no distant or mediastinal disease progression undergo lobectomy, pneumonectomy, or segmentectomy with standard radical mediastinal lymph node dissection.
NOTE: *Bevacizumab is only administered during courses 1 and 2.
After completion of study treatment, patients are followed periodically for 8 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 |
|---|---|---|
| bevacizumabAlso: AvastinNeoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles. | Biological | – |
| carboplatinAlso: ParaplatinNeoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles. | Drug | – |
| docetaxelAlso: TaxotereNeoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles. | Drug | – |
| conventional surgeryAlso: ResectionStandard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only. | Procedure or surgery | – |
Primary outcome
Clinical response rate by CT scan after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
10 secondary outcomes
Pathologic response rate after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
Resectability rate after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
Median survival at 2 years after surgery
Time frame: 2 years after surgery
Safety after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
Overall survival at 2 years after surgery
Time frame: 2 years after surgery
Time to treatment failure within 2 years after surgery
Time frame: 2 years after surgery
Correlation of serum VEGF levels prior to neoadjuvant therapy with primary and secondary objectives prior to start of induction treatment
Time frame: Before induction treatment
Correlation of serum VEGF expression in resected tumor with primary and secondary objectives
Time frame: After surgical removal of tumor
Correlation of VEGF levels measured immediately after resection and after adjuvant bevacizumab therapy with primary and secondary objectives
Time frame: After resection and after adjuvant bevacizumab
Assay additional downstream VEGF activation pathway markers
Time frame: At any time during the study
Results and safety
The study was stopped early (reason given: Terminated due to low subject accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
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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.
Sarita Dubey, MD study chair
University of California, San Francisco
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, carboplatin and docetaxel in people with Lung Cancer, run by University of California, San Francisco 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: stopped early, as of the sponsor's last update on 9 Feb 2011. 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 was stopped early (reason given: Terminated due to low subject accrual). 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?
Clinical response rate by CT scan after 3 courses of induction treatment (time frame: After 3 cycles of induction treatment). 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 9 Feb 2011.