Non Small Cell Lung CancerPhase 2H3E-US-X072NCT00614822
Carboplatin, Bevacizumab and Pemetrexed in Advanced Non Small Cell Lung Cancer
A Phase 2 study testing Carboplatin, Pemetrexed and Bevacizumab in people with Non Small Cell Lung Cancer, run by Christiana Care Health Services.
Trial summary
The purpose of this study is to look for an improvement in progression free survival with the combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed advanced/metastatic non small cell lung cancer. Overall survival and safety will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Carboplatin, Pemetrexed and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to 22 Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced stage NSCLC (IIIB with malignant pleural effusion; T4 [on basis on satellite lesion] N2, 3; or stage IV) excluding squamous cell histology, with measurable or evaluable disease.
- Prior chemotherapy therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
- Palliative radiotherapy to painful bony metastases will be permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression.
- Life expectancy of at least 3 months.
- ECOG Performance status 0-1.
- Age 18 or higher.
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- Willingness to use appropriate contraception to avoid pregnancy during the study (female patient or female partner of a male patient)
- Patients must have normal organ and marrow function as defined below:
- leukocytes greater than or equal to3,000/µl ANC greater than or equal to 1,500/µl platelets greater than or equal to 100,000/µl total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance ≥ 45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Ability to sign informed consent
- Ability to take folic acid, Vitamin B12 and dexamethasone as per protocol
- Ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
Who cannot join
- Patients meeting any of the following criteria are ineligible for study entry:
- Prior cytotoxic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
- Prior definitive chest irradiation (radiation of rib or spine mets permitted)
- Known brain metastases (unless previously resected and radiated)
- Prior treatment with bevacizumab or pemetrexed
- History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab or carboplatin
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- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study.
- Concomitant chemotherapy, radiotherapy or investigational agents.
- Evidence of bleeding diathesis or coagulopathy.
- Use of anti-coagulant agents warfarin (1mg, by mouth, daily for port maintenance permitted), heparin (ASA, NSAID permitted).
- Pregnant (positive pregnancy test) or lactating women.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0.
- Urine protein creatinine ratio 1.0 at screening. -History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to Day 0.
- Serious, non-healing wound, ulcer, or bone fracture.
- Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist. -Recent history of hemoptysis (bright red blood of 1/2 teaspoon or more)- within one month of study entry
- Significant co-morbidities including:
- Blood pressure of 150/100 mmHg Unstable angina New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix B) History of myocardial infarction within 6 months History of stroke within 6 months Clinically significant peripheral vascular disease
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Another active malignancy except for non-melanoma skin cancers.
- Clinically significant pleural, pericardial, and/or peritoneal effusions unless drained or controlled prior to study entry.
- Undrainable, clinically relevant effusions and presence of third space fluid which cannot be controlled by drainage.
- Hepatic impairment as evidenced by Bilirubin greater than 1.5 times the upper limit of normal Transaminases greater than 3.0 times limit of normal (ULN), except in presence of known hepatic metastasis, wherein may be up to 5 times ULN
- Any CTCAE Version 3.0 Grade 3 or 4 non hematologic toxicity
About this study
Official title: A Phase II Trial of Carboplatin, Bevacizumab and Pemetrexed in Advanced Non-Small Cell Lung Cancer
The purpose of this study is to look for an improvement in progression free survival with the combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed advanced/metastatic non small cell lung cancer. Overall survival and safety will also be assessed.
Read the detailed description
Carboplatin: AUC 5 IV over 30-60 minutes on day 1 Pemetrexed: 500mg/M2 IV over 10 minutes on day 1 Bevacizumab: 15mg/kg IV over 90 minutes on day 1 (if rate is tolerated the 2nd dose may be decreased to 60 minutes and subsequent doses to 30 minutes This regimen will be administered every 6 weeks for up to a maximum of 6 cycles if the patient tolerates the treatment and has stable disease. Bevacizumab will be continues if tolerated for up to 1 year at every 3 week intervals.
Folic acid 1mg by mouth daily, Vitamin B12 1000 ug IM every 9 weeks and Dexamethasone 4mg by mouth twice a day and and antiemetic may be prescribed by the physician investigator to help reduce side effects associated with the Pemetrexed. The Folic acid and Vitamin B12 will continue until 3 weeks after the end of treatment.
Physical exams, vital signs and blood work will be done prior to each chemotherapy cycle. A urine dipstick to check for protein in the urine will be done prior to the first treatment and before cycles 3 and 5. A CAT scan of the chest will be done pretreatment, prior to cycles 3 and 5 and at the end of treatment.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Carboplatin, Pemetrexed and Bevacizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin, Pemetrexed and BevacizumabDrug
Also called Paraplatin, Alimta, Avastin
Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| one arm for study | Other | Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease. Receives: Drug: Carboplatin, Pemetrexed and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").
Overall Survival
Overal survival was defined as time between the date of treatment assignment and the date of death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").
Secondary outcomes (2)
Number of Participants With Complete and Partial Tumor Responses
A complete response (CR),was disappearance of all target lesions on CT scan and absence of appearance of any new lesion was required. Partial response (PR) was assessed by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions without appearance of any new lesions. Progressive disease (PD) was defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions. Patients were assessed to have stable disease if neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, without appearance of new lesions. Patients who received one or more cycles were evaluable for response.
Measured: Patients were enrolled over a 24 month period for treatment visits. After end of treatment visits, subjects were seen or contacted every 3 months for survival data. Median follow up was 49 weeks (6 weeks to death.
Number of Participants With Adverse Events
Measured by adverse events such as grade 4 toxicities, hospitalizations for toxicities, fever and neutropenia events, and clinically significant bleeding/thrombotic events.
Measured: Subjects were seen or contacted every 3 months with medain follow up of 49 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startNov 2007
- Primary completion22 Aug 2016
- Study completion22 Aug 2016
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 Non Small Cell 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Michael Guarino, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614822
- Sponsor's protocol ID
- 24091
- Other IDs
- Eli Lilly H3E-US-X072
- Acronym
- H3E-US-X072
- Status last verified
- Mar 2019
- First submitted
- 30 Jan 2008
- Last updated
- 20 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 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Carboplatin, Bevacizumab and Pemetrexed in Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00614822
- Acronym / sponsor ID
- H3E-US-X072 / 24091
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2007
- Primary completion
- 22 Aug 2016 (actual)
- Study completion
- 22 Aug 2016 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 20 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look for an improvement in progression free survival with the combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed advanced/metastatic non small cell lung cancer. Overall survival and safety will also be assessed.
Detailed description
Carboplatin: AUC 5 IV over 30-60 minutes on day 1 Pemetrexed: 500mg/M2 IV over 10 minutes on day 1 Bevacizumab: 15mg/kg IV over 90 minutes on day 1 (if rate is tolerated the 2nd dose may be decreased to 60 minutes and subsequent doses to 30 minutes This regimen will be administered every 6 weeks for up to a maximum of 6 cycles if the patient tolerates the treatment and has stable disease. Bevacizumab will be continues if tolerated for up to 1 year at every 3 week intervals.
Folic acid 1mg by mouth daily, Vitamin B12 1000 ug IM every 9 weeks and Dexamethasone 4mg by mouth twice a day and and antiemetic may be prescribed by the physician investigator to help reduce side effects associated with the Pemetrexed. The Folic acid and Vitamin B12 will continue until 3 weeks after the end of treatment.
Physical exams, vital signs and blood work will be done prior to each chemotherapy cycle. A urine dipstick to check for protein in the urine will be done prior to the first treatment and before cycles 3 and 5. A CAT scan of the chest will be done pretreatment, prior to cycles 3 and 5 and at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm for study | Other | Drug: Carboplatin, Pemetrexed and BevacizumabCarboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Advanced stage NSCLC (IIIB with malignant pleural effusion; T4 [on basis on satellite lesion] N2, 3; or stage IV) excluding squamous cell histology, with measurable or evaluable disease.
- Prior chemotherapy therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
- Palliative radiotherapy to painful bony metastases will be permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression.
- Life expectancy of at least 3 months.
- ECOG Performance status 0-1.
Key exclusion criteria (24 listed)
- Prior cytotoxic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
- Prior definitive chest irradiation (radiation of rib or spine mets permitted)
- Known brain metastases (unless previously resected and radiated)
- Prior treatment with bevacizumab or pemetrexed
- History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab or carboplatin
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 |
|---|---|---|
| Carboplatin, Pemetrexed and BevacizumabAlso: Paraplatin, Alimta, AvastinCarboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles | Drug | one arm for study |
Primary outcome
Progression Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").
Overall Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").
Overal survival was defined as time between the date of treatment assignment and the date of death
2 secondary outcomes
Number of Participants With Complete and Partial Tumor Responses
Time frame: Patients were enrolled over a 24 month period for treatment visits. After end of treatment visits, subjects were seen or contacted every 3 months for survival data. Median follow up was 49 weeks (6 weeks to death.
Number of Participants With Adverse Events
Time frame: Subjects were seen or contacted every 3 months with medain follow up of 49 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 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.
Michael Guarino, MD principal investigator
Christiana Care Health Services
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Pemetrexed and Bevacizumab in people with Non Small Cell Lung Cancer, run by Christiana Care Health Services.
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 12 inclusion and 24 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 20 Mar 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?
Progression Free Survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").). The study lists 2 primary outcomes in all. 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 20 Mar 2019.