Lung CancerPhase 1/2NCT00411593
Phase I-II for Patients With Recurrent or Refractory Non-small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing Bevacizumab and Bortezomib in people with Lung Cancer, run by M.D. Anderson Cancer Center.
Trial summary
Primary Objective The primary objective of this phase I-II study is to evaluate: Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with bevacizumab given every 3 weeks. 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 and Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to May 2007
- Phase
- Phase 1/2
- 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
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal (Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential) or surgically sterilized or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
- All patients must have an Eastern Cooperative Oncology Group (ECOG)Performance Status of 0 - 2
- Patients must have histologically or cytologically proven selected Stage IIIB (T4 lesion due to malignant pleural or pericardial effusion) or Stage IV advanced non-small cell lung cancer or recurrent disease after previous surgery and/or radiation.
- No history of or active brain metastases
- Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.
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- Recurrent or progressive cancer can be within a previously radiated site
- Patients must have received one or two prior systemic therapies, one of which contained a platinum compound. No prior Bortezomib or antiangiogenic agent is permitted. Prior radiation is permitted; however, at least two weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all associated toxicities at the time of registration. At least two weeks must have elapsed since surgery (thoracic or other major surgeries) and patients must have recovered from all associated toxicities at the time of registration.
- Patients must have a serum creatinine </= the institutional upper limit of normal (i.e. 1.5 mg/dL) AND a creatinine clearance >/= 40 cc/min determined by either urine collection and testing or calculation using the following formula: Calculated Creatinine Clearance = (140 - age) * Weight(kg) * (0.85 if female)/ 72 * creatinine (mg/dL)
- Patients must have an Absolute neutrophil count (ANC)>/= 2,000/µl and platelet count >/= 100,000/µl obtained within 28 days prior to registration. Hemoglobin: >9.0 * 10^9/L
- Patients must have adequate hepatic function documented by a serum bilirubin </= institutional upper limit of normal (1.0) and liver enzymes (serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT)) </= 3.0 * the institutional upper limit of normal obtained within 28 days prior to registration
- Peripheral neuropathy, if present, must be < Grade 2 (NCI Common Terminology Criteria for Adverse Events Version 3.0).
- Patients known to be HIV-positive and taking HAART therapy are not eligible due to possible pharmacokinetic interactions
- Patients must not be planning to receive any other concomitant anticancer treatment including chemotherapy, radiation therapy, biologic agents or any other investigational drugs
- Patient must be >/= 18 years of age.
- Patients must be informed of the investigation nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study. Participation in an experimental drug study within 4 weeks of the first treatment on this trial: Blood pressure > 140/90 mm Hg, History of stroke within 6 months, Clinically significant peripheral vascular disease, Evidence of bleeding diathesis or coagulopathy, Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Urine protein: creatinine ratio >/= 1.0 at screening
- Serious non-healing wound, ulcer, or bone fracture
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class II or heart failure, unstable angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, and ECG abnormality at Screening has to be documented by the investigator as not medically relevant
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- Patients with squamous histology
- Patients with hematemesis or more than ½ teaspoon of hemoptysis within 6 months of study entry.
- Patients requiring full dose oral or parenteral anticoagulation.
- Abdominal fistula, GI perforation, or abdominal abscess within the last 6 months
- Patient has hypersensitivity to boron or mannitol
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Patient has received other investigational drugs within 28 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- No other prior or concurrent malignancy is allowed except for: non-melanoma skin cancers, in situ cervical cancer, and any cancer from which the patient has been disease-free for 3 years or more.
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Patients requiring treatment with Nonsteroidal anti-inflammatory drugs (NSAIDS), antiplatelet agents, or aspirin > 325 mg/day
About this study
Official title: Phase I-II Study of Avastin®+ Bortezomib for Patients With Recurrent or Refractory Non-Squamous NSCLC
Primary Objective
The primary objective of this phase I-II study is to evaluate:
- Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with bevacizumab given every 3 weeks.
- Phase II: Using the MTD established in phase I, assess efficacy of the combination as indicated by progression-free survival.
Secondary Objectives
The secondary objectives of this study are to evaluate:
- Response rates and duration of response
- 1 year survival
- Overall survival
- Qualitative and quantitative toxicity
- Circulating endothelial cells (CECs) prior to treatment, prior to cycle 2, and/or at the time of progression
Read the detailed description
Bortezomib is designed to enter cells and interfere with a substance found inside cells that is responsible for allowing cells to divide.
Avastin® is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
If you are found to be eligible to take part in this study, depending on when you enroll, you will be assigned to one of up to 4 treatment groups. There will be 3 participants in each of the first few groups, and an additional 30 participants in the last group. The first few (2 or 3) groups are part of the first phase of the study, and the last group (3rd or 4th) is part of the second phase. All participants will receive the same dose level of Avastin®. The amount of bortezomib you receive will depend on when you enroll in the study. The exact dose of bortezomib that you receive will be based on your height and weight. In the first phase of the study, groups of participants will be assigned to one of 2 bortezomib dose levels. The first group will receive the highest dose. The next groups will receive either that same dose level, or if intolerable side effects occurred, a lower dose level. For the second part of the study, the last group will receive the highest dose level that did not cause intolerable side effects in the other groups.
A cycle of treatment is 3 weeks (21 days). Bortezomib will be given once a week for the first 2 weeks of each cycle. Avastin® will be given every 3 weeks. (On Day 1 of each cycle, you will receive both bortezomib and Avastin®.)
Bortezomib will be injected through a needle in your vein. Each injection will last about 3-5 seconds. After receiving each dose of bortezomib, the clinic staff will check how well you are tolerating the drug. During that time, you will be asked about any side effects you may be experiencing. Your doctor may decrease or pause the dose of bortezomib if you experience certain side effects.
Avastin® will be given as an infusion through a needle in your vein, over 90 minutes. If you tolerate the 90-minute infusion well, the second infusion will be given over 60 minutes. If you tolerate the 60-minute infusion well, all following infusions will be given over 30 minutes. If you do not tolerate the shorter infusion time, future infusion times will be increased until a tolerable level is reached.
Every 3 weeks, you will have a physical exam, including measurement of vital signs and weight. Blood (about 2 teaspoons) will be drawn for routine tests. You will have a performance status evaluation. On Day 8 of each cycle of treatment, blood (about 2 teaspoons) will be drawn for routine tests. The level of protein in your urine will be monitored at least every 6 weeks.
You may continue receiving study treatment for as long as the cancer responds to the treatment or for up to 1 year. Your doctor may decide to take you off this study if you experience intolerable side effects or your health gets worse.
After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) will be drawn for routine tests. You will have a performance status evaluation, chest x-ray, and a CT or MRI scan. On an indefinite basis, the study nurse will contact you by telephone from time to time to see how you are doing.
This is an investigational study. Bortezomib has been FDA approved and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy. Avastin® has been FDA approved for the treatment of metastatic colorectal cancer and non-small cell lung cancer. However, bortezomib and Avastin® are not FDA-approved for this type of cancer, and they have been authorized for use together in research only. Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- Bevacizumab, Bortezomib
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, Bortezomib, Bevacizumab
- 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.
BevacizumabDrug
Also called Avastin, Anti-VEGF Monoclonal Antibody, rhuMAb-VEGF
15 g/kg by vein every 3 weeks on day 1 of each cycle.
BortezomibDrug
Also called Velcade, LDP-341, MLN341, PS-341
Phase I Starting dose: 1.6 mg/m2 by vein on days 1, 8 of each 3 week cycle.
Phase II: MTD from Phase I.
| Study group | Role | What they receive |
|---|---|---|
| Avastin® + Bortezomib | Experimental | Phase I - 3 * 3 design, enrolling patients to receive Avastin® at a fixed dose of 15 mg/kg every 3 weeks and Bortezomib dosed at 1.6 mg/m2 weekly for 2 weeks out of 3.
Phase II - The MTD for Bortezomib from the weekly schedule that is chosen will be combined with Avastin® to estimate the rate of progression-free survival. Receives: Drug: Bevacizumab; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD is defined as the highest dose level in which 6 patients have been treated with 2 patients with dose limiting toxicity (DLT).
Measured: 21 days
Secondary outcomes (1)
Progression Free Survival
Patients' progression free survival, 1 year survival and overall survival will be assessed. The survival rate for time to event outcome will be estimated by Kaplan-Meier method. All patients will be followed until death.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: Lack of Patient 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 M.D. Anderson Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Bonnie S. Glisson, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411593
- Sponsor's protocol ID
- 2006-0045
- Status last verified
- Feb 2012
- First submitted
- 12 Dec 2006
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Avastin®+ Bortezomib for Patients With Recurrent or Refractory Non-Squamous NSCLC
- ClinicalTrials.gov ID
- NCT00411593
- Acronym / sponsor ID
- 2006-0045
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, Bortezomib, Bevacizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Patient Accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Genentech, Inc.
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 14 Dec 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.
Primary Objective
The primary objective of this phase I-II study is to evaluate:
- Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with bevacizumab given every 3 weeks.
- Phase II: Using the MTD established in phase I, assess efficacy of the combination as indicated by progression-free survival.
Secondary Objectives
The secondary objectives of this study are to evaluate:
- Response rates and duration of response
- 1 year survival
- Overall survival
- Qualitative and quantitative toxicity
- Circulating endothelial cells (CECs) prior to treatment, prior to cycle 2, and/or at the time of progression
Detailed description
Bortezomib is designed to enter cells and interfere with a substance found inside cells that is responsible for allowing cells to divide.
Avastin® is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
If you are found to be eligible to take part in this study, depending on when you enroll, you will be assigned to one of up to 4 treatment groups. There will be 3 participants in each of the first few groups, and an additional 30 participants in the last group. The first few (2 or 3) groups are part of the first phase of the study, and the last group (3rd or 4th) is part of the second phase. All participants will receive the same dose level of Avastin®. The amount of bortezomib you receive will depend on when you enroll in the study. The exact dose of bortezomib that you receive will be based on your height and weight. In the first phase of the study, groups of participants will be assigned to one of 2 bortezomib dose levels. The first group will receive the highest dose. The next groups will receive either that same dose level, or if intolerable side effects occurred, a lower dose level. For the second part of the study, the last group will receive the highest dose level that did not cause intolerable side effects in the other groups.
A cycle of treatment is 3 weeks (21 days). Bortezomib will be given once a week for the first 2 weeks of each cycle. Avastin® will be given every 3 weeks. (On Day 1 of each cycle, you will receive both bortezomib and Avastin®.)
Bortezomib will be injected through a needle in your vein. Each injection will last about 3-5 seconds. After receiving each dose of bortezomib, the clinic staff will check how well you are tolerating the drug. During that time, you will be asked about any side effects you may be experiencing. Your doctor may decrease or pause the dose of bortezomib if you experience certain side effects.
Avastin® will be given as an infusion through a needle in your vein, over 90 minutes. If you tolerate the 90-minute infusion well, the second infusion will be given over 60 minutes. If you tolerate the 60-minute infusion well, all following infusions will be given over 30 minutes. If you do not tolerate the shorter infusion time, future infusion times will be increased until a tolerable level is reached.
Every 3 weeks, you will have a physical exam, including measurement of vital signs and weight. Blood (about 2 teaspoons) will be drawn for routine tests. You will have a performance status evaluation. On Day 8 of each cycle of treatment, blood (about 2 teaspoons) will be drawn for routine tests. The level of protein in your urine will be monitored at least every 6 weeks.
You may continue receiving study treatment for as long as the cancer responds to the treatment or for up to 1 year. Your doctor may decide to take you off this study if you experience intolerable side effects or your health gets worse.
After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) will be drawn for routine tests. You will have a performance status evaluation, chest x-ray, and a CT or MRI scan. On an indefinite basis, the study nurse will contact you by telephone from time to time to see how you are doing.
This is an investigational study. Bortezomib has been FDA approved and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy. Avastin® has been FDA approved for the treatment of metastatic colorectal cancer and non-small cell lung cancer. However, bortezomib and Avastin® are not FDA-approved for this type of cancer, and they have been authorized for use together in research only. Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin® + Bortezomib | Experimental | Drug: Bevacizumab, Drug: BortezomibPhase I - 3 * 3 design, enrolling patients to receive Avastin® at a fixed dose of 15 mg/kg every 3 weeks and Bortezomib dosed at 1.6 mg/m2 weekly for 2 weeks out of 3. Phase II - The MTD for Bortezomib from the weekly schedule that is chosen will be combined with Avastin® to estimate the rate of progression-free survival. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal (Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential) or surgically sterilized or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
- All patients must have an Eastern Cooperative Oncology Group (ECOG)Performance Status of 0 - 2
- Patients must have histologically or cytologically proven selected Stage IIIB (T4 lesion due to malignant pleural or pericardial effusion) or Stage IV advanced non-small cell lung cancer or recurrent disease after previous surgery and/or radiation.
- No history of or active brain metastases
Key exclusion criteria (16 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study. Participation in an experimental drug study within 4 weeks of the first treatment on this trial: Blood pressure > 140/90 mm Hg, History of stroke within 6 months, Clinically significant peripheral vascular disease, Evidence of bleeding diathesis or coagulopathy, Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Urine protein: creatinine ratio >/= 1.0 at screening
- Serious non-healing wound, ulcer, or bone fracture
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: Avastin, Anti-VEGF Monoclonal Antibody, rhuMAb-VEGF15 g/kg by vein every 3 weeks on day 1 of each cycle. | Drug | Avastin® + Bortezomib |
| BortezomibAlso: Velcade, LDP-341, MLN341, PS-341Phase I Starting dose: 1.6 mg/m2 by vein on days 1, 8 of each 3 week cycle. Phase II: MTD from Phase I. | Drug | Avastin® + Bortezomib |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 21 days
MTD is defined as the highest dose level in which 6 patients have been treated with 2 patients with dose limiting toxicity (DLT).
1 secondary outcome
Progression Free Survival
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
- UT MD Anderson Cancer Center websiteLink 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.
Bonnie S. Glisson, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab and Bortezomib in people with Lung Cancer, run by M.D. Anderson Cancer Center.
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 16 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: withdrawn, as of the sponsor's last update on 8 Feb 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
Maximum Tolerated Dose (MTD) (time frame: 21 days). 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 8 Feb 2012; AzTrials last refreshed its copy on 3 Nov 2026.