Non-squamous Non-small Cell Lung CancerPhase 2NCT01057212
Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing ixabepilone and bevacizumab in people with Non-squamous Non-small Cell Lung Cancer, run by Providence Health & Services at 1 site in United States.
Trial summary
This is a non-randomized, open-label, single arm phase II trial of the combination of bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC progressive after first or second-line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- ixabepilone and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2013
- 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
Who may be able to join
- Histologic or cytologic diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC), excluding squamous cell-predominant subtype. NSCLC NOS (not otherwise specified) are eligible.
- Patients must have had at least one but no more than two prior systemic chemotherapeutic regimens for metastatic disease. Prior neoadjuvant or adjuvant chemotherapy will not be included in the assessment as a prior chemotherapeutic regimen. Prior therapy with taxanes is allowed. Prior therapy with bevacizumab is allowed.
- Prior chemotherapy or therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
- Zubrod performance status of 0 or 1.
- Patients must have measurable or evaluable disease as defined by RECIST.
- Treated brain metastases will be allowed, provided they are asymptomatic. Radiation treatment for brain metastasis must have been completed at least 2 weeks prior to enrollment. Patients must demonstrate stable symptoms and seizure control on a consistent dose of anticonvulsants for at least 2 weeks prior to enrollment. Patients must be off corticosteroids for at least 2 weeks. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, KINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
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- Radiation for symptomatic lesions outside the CNS must have been completed at least 2 weeks prior to study enrollment. If measurable disease is within the radiation field, there must be evidence of clear progression (using RECIST criteria) at the time of study enrollment.
- Major surgical procedures must have been performed >28 days prior to study treatment. Portacath placement must have been performed >14 days prior to study treatment. Minor surgical procedures (fine needle aspiration, core biopsy, or mediastinoscopy) must have been performed >7 days prior to study treatment.
- Patients must have normal organ and marrow function as defined below:
- leukocytes > 3,000/uL
- absolute neutrophil count > 1,500/uL
- platelets > 100,000/uL
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
- creatinine < 1.5 mg/dL, OR
- calculated creatinine clearance > 40 mL/min
- Estimated life expectancy of greater than 12 weeks.
- Patients must be able to sign informed consent.
- Patients must be >18 years of age. Both men and women and members of all races and ethnic groups will be included.
- Patients must either not be of child bearing potential or, if female, have a negative serum pregnancy test within 72 hours prior to Day 1. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a vasectomy, hysterectomy, bilateral tubal ligation, bilateral oophorectomy) or they are postmenopausal with no menses for at least 12 months. Patients of childbearing potential must be willing to use adequate barrier contraception for the duration of study participation and at least 30 days after study completion.
Who cannot join
- NSCLC with predominant squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable).
- History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 1 month prior to Day 1.
- Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone (within the last two weeks prior to Day 1), as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- Inability to comply with study and/or follow-up procedures.
- An investigational agent within 3 weeks of Day 1.
- Patients with greater than grade 1 neuropathy.
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- Pregnant (positive pregnancy test) or lactating.
- Serious concomitant medical disorder, including active infection.
- Active second primary malignancy at the time of study enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone or Cremophor EL (polyoxyethylated castor oil).
- History of co-existing psychiatric illness that could impair compliance with study protocol.
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction or unstable angina within 6 months prior to Day 1.
- History of stroke or transient ischemic attack within 6 months prior to Day 1 of treatment.
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection).
- Symptomatic peripheral vascular disease.
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study.
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1.
- Portacath placement within 14 days prior to Day 1.
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1.
- Serious, non-healing wound, active ulcer, or untreated bone fracture.
- Proteinuria at screening as demonstrated by either:
- Urine protein: creatinine (UPC) ratio ≥ 1.0 at screening OR
- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at screening should undergo a 24 hour urine collection and must demonstrate ≤ 500 mg of protein in 24 hours to be eligible).
- Known hypersensitivity to any component of bevacizumab.
- Prior discontinuation of bevacizumab due to treatment-related toxicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: Phase II Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Progressive After First-line Therapy
This is a non-randomized, open-label, single arm phase II trial of the combination of bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC progressive after first or second-line therapy. The main objective is to evaluate the progression-free survival in patients with advanced or metastatic non-squamous NSCLC being treated with ixabepilone and bevacizumab.
Read the detailed description
The first six patients will be enrolled in a lead-in phase of the study utilizing a reduced dose of ixabepilone. Patients will be monitored for safety and toxicity. If the combination is found to be tolerable and feasible, accrual will continue with the full-dose regimen. Toxicity will be monitored in real-time by the study investigators. Should unexpected or increased toxicity be detected, trial accrual will be halted for full analysis.
Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks. Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- ixabepilone, bevacizumab
- Keywords
- advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ixabepiloneDrug
Also called IXEMPRA®
Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled.
bevacizumabDrug
Also called Avastin
Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab and Ixabepilone | Experimental | Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks. Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule to the remaining 40 patients. Receives: Drug: ixabepilone; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: at week 8, week 16, and every 8 weeks until disease progression or removal from study
Secondary outcomes (2)
To evaluate the overall response rate using RECIST criteria
Measured: at week 8, week 16, and every 8 weeks until disease progression or removal from study
toxicities associated with treatment combination in advanced non-squamous NSCLC
Measured: all treatment days and every 2 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Lack of support from pharmaceutical collaborator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Rachel Sanborn, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057212
- Sponsor's protocol ID
- 09-97B
- Status last verified
- Sep 2015
- First submitted
- 12 Jan 2010
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Progressive After First-line Therapy
- ClinicalTrials.gov ID
- NCT01057212
- Acronym / sponsor ID
- 09-97B
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Keywords
- advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of support from pharmaceutical collaborator.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Genentech, Inc., Bristol-Myers Squibb
- Study start
- Feb 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jan 2010 (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.
This is a non-randomized, open-label, single arm phase II trial of the combination of bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC progressive after first or second-line therapy. The main objective is to evaluate the progression-free survival in patients with advanced or metastatic non-squamous NSCLC being treated with ixabepilone and bevacizumab.
Detailed description
The first six patients will be enrolled in a lead-in phase of the study utilizing a reduced dose of ixabepilone. Patients will be monitored for safety and toxicity. If the combination is found to be tolerable and feasible, accrual will continue with the full-dose regimen. Toxicity will be monitored in real-time by the study investigators. Should unexpected or increased toxicity be detected, trial accrual will be halted for full analysis.
Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks. Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and Ixabepilone | Experimental | Drug: ixabepilone, Drug: bevacizumabBevacizumab will be administered intravenously, 10 mg/kg, every two weeks. Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule to the remaining 40 patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologic or cytologic diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC), excluding squamous cell-predominant subtype. NSCLC NOS (not otherwise specified) are eligible.
- Patients must have had at least one but no more than two prior systemic chemotherapeutic regimens for metastatic disease. Prior neoadjuvant or adjuvant chemotherapy will not be included in the assessment as a prior chemotherapeutic regimen. Prior therapy with taxanes is allowed. Prior therapy with bevacizumab is allowed.
- Prior chemotherapy or therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
- Zubrod performance status of 0 or 1.
- Patients must have measurable or evaluable disease as defined by RECIST.
Key exclusion criteria (29 listed)
- NSCLC with predominant squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable).
- History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 1 month prior to Day 1.
- Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone (within the last two weeks prior to Day 1), as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- Inability to comply with study and/or follow-up procedures.
- An investigational agent within 3 weeks of Day 1.
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 |
|---|---|---|
| ixabepiloneAlso: IXEMPRA®Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled. | Drug | Bevacizumab and Ixabepilone |
| bevacizumabAlso: AvastinBevacizumab will be administered intravenously, 10 mg/kg, every two weeks. | Drug | Bevacizumab and Ixabepilone |
Primary outcome
progression-free survival
Time frame: at week 8, week 16, and every 8 weeks until disease progression or removal from study
2 secondary outcomes
To evaluate the overall response rate using RECIST criteria
Time frame: at week 8, week 16, and every 8 weeks until disease progression or removal from study
toxicities associated with treatment combination in advanced non-squamous NSCLC
Time frame: all treatment days and every 2 months post-treatment
Results and safety
The study was stopped early (reason given: Lack of support from pharmaceutical collaborator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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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.
Rachel Sanborn, MD principal investigator
Providence Health & Services
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 ixabepilone and bevacizumab in people with Non-squamous Non-small Cell Lung Cancer, run by Providence Health & Services 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?
The sponsor lists 20 inclusion and 29 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: stopped early, as of the sponsor's last update on 7 Sep 2015. 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: Lack of support from pharmaceutical collaborator.). 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?
progression-free survival (time frame: at week 8, week 16, and every 8 weeks until disease progression or removal from study). 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 7 Sep 2015.