Lung CancerPhase 2NCT00234052
Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Phase 2 study testing bevacizumab, carboplatin and pemetrexed in people with Lung Cancer, run by Northwestern University at 5 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bevacizumab, carboplatin and pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jul 2005to 28 Nov 2011
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically* or cytologically* confirmed non-small cell lung cancer
- Any histology, except squamous cell carcinoma, allowed
- Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible
- No histology in close proximity to a major vessel or cavitation NOTE: *Histologic or cytologic elements may be established on metastatic tumor aspirates or biopsy
- Meets 1 of the following stage criteria:
- Stage IIIB disease (with malignant pleural effusion)
- Stage IV disease
- Recurrent disease
- Measurable or non-measurable disease
- No known CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- No history of hemorrhagic disorders
Hepatic
- Bilirubin < 1.5 mg/dL
- AST and ALT < 5 times upper limit of normal
- INR < 1.5
- PTT normal
Renal
- Creatinine clearance ≥ 45 mL/min
- Urine protein:creatinine ≤ 1.0 by spot urinalysis
Cardiovascular
- No myocardial infarction within the past 6 months
- No New York Heart Association class II-IV congestive heart failure
- No unstable angina pectoris
- No serious cardiac arrhythmia requiring medication
- No stroke within the past 6 months
- No peripheral vascular disease ≥ grade 2
- No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
- Patients with a history of hypertension allowed provided blood pressure is well controlled on a stable regimen of anti-hypertensive therapy
- No history of thrombotic disorders
- No other clinically significant cardiovascular disease
Pulmonary
- No history of gross hemoptysis, defined as bright red blood of a ½ teaspoon or more
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be willing and able to take daily oral folic acid, intermittent vitamin B_12 injections, and corticosteroid premedication
- No ongoing or active infection
- No serious, non-healing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 3 weeks since prior immunotherapy
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- More than 3 weeks since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy
Surgery
- More than 4 weeks since prior major surgery
- More than 1 week since prior minor surgery, fine needle aspiration, or core biopsy
- No concurrent major surgery
Other
- Recovered from all prior therapy
- More than 4 weeks since prior and no concurrent participation in another experimental drug study
- No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2 days after each pemetrexed disodium infusion (5 days before and 2 days after each pemetrexed disodium infusion for NSAIDs with a long half-life [e.g., naproxen, rofecoxib, or celecoxib])
- No concurrent therapeutic anticoagulation
- Concurrent prophylactic anticoagulation for venous access devices allowed provided requirements for INR and PTT are met
- No concurrent administration of any of the following:
- Chronic daily treatment with aspirin (> 325 mg per day)
- NSAIDs known to inhibit platelet function, including any of the following:
- Dipyridamole
- Ticlopidine
- Clopidogrel
- Cilostazol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, 60612
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068-1174
About this study
Official title: Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin, pemetrexed disodium, and bevacizumab.
Secondary
- Determine the response rate and duration of response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with complete response, partial response, or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab, carboplatin, pemetrexed
- Keywords
- recurrent non-small cell lung cancer, 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
- 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
Also called Avastin
5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)
carboplatinDrug
Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)
pemetrexedDrug
Also called pemetrexed disodium
Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Carboplatin + pemetrexed + bevacizumab Receives: Biological: bevacizumab; Drug: carboplatin; Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression Free Survival
Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.
Measured: Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)
Secondary outcomes (4)
Overall Response Rate
Overall Response Rate (ORR) of patients treated with carboplatin, pemetrexed, and bevacizumab combination is defined as the number of patients who's best response is a Complete Response (CR) plus Partial Response (PR)as recorded from the start of treatment until disease progression as assessed by RECIST 1.0.
CR=Disappearance of all target lesions for a minimum of 4 weeks. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions for a minimum of 4 weeks, taking as reference the baseline sum LD. No simultaneous increase in the size of any lesion or the appearance of a new lesion may occur.
Measured: Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months)
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
To characterize the toxicity profile of carboplatin, pemetrexed and bevacizumab combination treatment.
Toxicity data will be collected from initiation of treatment, every cycle, until 30 days post last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). Only toxicity determined to be a least possibility related to at least one study drug and grade 3 or 4 was collected for this outcome measure.
In general adverse events (AEs) will be graded according to the following:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Measured: From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51)
Overall Survival Rate
Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined from the time of registration to the study until death from any cause. Patients that are lost to follow up will be censored from last documentation of survival status.
Measured: During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.
Duration of Response
Duration of Response for patients treated with the combination of carboplatin, pemetrexed and bevacizumab is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date of documented progressive disease.
Measured: From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study start28 Jul 2005
- Primary completion1 Mar 2011
- Study completion28 Nov 2011
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.
- More trials run by Northwestern UniversityThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jyoti D. Patel, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234052
- Sponsor's protocol ID
- NU 04L2
- Other IDs
- NU-04L2, STU00007415
- Status last verified
- Jan 2019
- First submitted
- 5 Oct 2005
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00234052
- Acronym / sponsor ID
- NU 04L2
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Jul 2005 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 28 Nov 2011 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Posted 16 May 2019
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 carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin, pemetrexed disodium, and bevacizumab.
Secondary
- Determine the response rate and duration of response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with complete response, partial response, or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 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)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: bevacizumab, Drug: carboplatin, Drug: pemetrexedCarboplatin + pemetrexed + bevacizumab |
Who may qualify
- Ages
- 18 to 120 years
- 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: Avastin5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks) | Biological | Treatment Arm |
| carboplatinAdministered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks) | Drug | Treatment Arm |
| pemetrexedAlso: pemetrexed disodiumAdministered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks) | Drug | Treatment Arm |
Primary outcome
Median Progression Free Survival
Time frame: Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)
Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.
4 secondary outcomes
Overall Response Rate
Time frame: Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months)
Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment
Time frame: From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51)
Overall Survival Rate
Time frame: During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.
Duration of Response
Time frame: From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jyoti D. Patel study chair
Robert H. Lurie Cancer Center
5 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, carboplatin and pemetrexed in people with Lung Cancer, run by Northwestern University at 5 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?
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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 16 May 2019). 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?
Median Progression Free Survival (time frame: Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)). 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 4 Jun 2019.