MesotheliomaPhase 2NCT00996385
Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma
A Phase 2 study testing Velcade (bortezomib) plus Eloxatin (oxaliplatin) in people with Mesothelioma, run by Columbia University at 1 site in United States.
Trial summary
Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Velcade (bortezomib) plus Eloxatin (oxaliplatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2014
- 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
- Patients must have histologically confirmed malignant pleural or peritoneal mesothelioma epithelial, sarcomatoid, or mixed subtype, not amenable to curative treatment with surgery. Patients with pleural mesothelioma will be clinically staged using the IMIG's staging criteria (section 17.1). Note that there is no staging system for peritoneal mesothelioma and those patients will only be followed for survival. Patients may be entered based on local pathology.
- Patients must have had ≤2 prior form of systemic chemotherapy. Prior intracavitary chemotherapy will be considered a prior regimen unless it was given for the purpose of pleurodesis. Immunomodulators will not be regarded as chemotherapy. Prior systemic treatment with pemetrexed plus cisplatin or carboplatin will not be a contraindication for treatment with VELCADE/ELOXATIN.
- Disease status must be that of measurable disease as defined by modified SWOG criteria.
- Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology.
- Measurable lesions: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scans. At least one level must have one rind measurement ≥15 mm. CT (specifically spiral CT) scans and MRI are the preferred methods of measurement.
- Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required. NOTE: Neither pleural effusions nor positive bone scans are considered measurable.
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- Patients may have undergone pleurodesis. If pleurodesis was recently performed, there must be at a minimum of a 2 week delay prior to treatment initiation. If a CT scan was done prior pleurodesis, a repeat CT scan for baseline evaluation will need to be performed prior to study entry. NOTE: For patients with clinically significant pleural effusions or ascites, consideration should be given to draining the fluid prior to initiating therapy.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (after any palliative measures including pleural drainage have occurred), see section 14.2.
- Patients must have an estimated life expectancy of at least 12 weeks.
- Patient assurance of study compliance and geographic proximity that allows for adequate follow-up.
- Patients must have adequate organ function at the screening visit as defined by the following laboratory values: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelet count ≥100 x 109/L Hemoglobin ≥9 g/dL. Albumin ≥ 2.5 g/dL Total Bilirubin ≤2.5 x ULN Alkaline phosphatase ≤3.0 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3.0 x ULN Creatinine ≤ 1.5 x ULN NOTE: total bilirubin, alkaline phosphatase, AST, ALT ≤5 x ULN acceptable if liver has tumor involvement
- 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.
- Patient must be a male or female of at least 18 years of age.
- Female subjects must either post-menopausal 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 subjects must agree to use an acceptable method for contraception for the duration of the study.
Who cannot join
- Has active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 3).
- Has experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality noted should be documented by the investigator as not medically relevant.
- Has been treated previously with VELCADE or ELOXATIN.
- Has had prior radiation therapy to the target lesion, unless the lesion is clearly progressing and the interval between the most recent radiation therapy and enrollment is at least 4 weeks.
- Has uncontrolled active systemic infection requiring therapy.
- Has a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
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- Female subject is pregnant or breast-feeding.
- Has had a serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
- Has had a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
- Has had any investigational agent within 4 weeks prior to enrollment into this study.
- Is unwilling to employ adequate means of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, or abstinence).
- Has disease which cannot be radiologically imaged.
- Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
Herbert Irving Comprehensive Cancer Center Clinical Research Management Office contact
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Robert N Taub, MD, PhD
Alain C Borczuk, MD
About this study
Official title: A Two Stage, Open Label, Phase II Study of VELCADE Plus ELOXATIN in Previously Treated Patients With Malignant Pleural or Peritoneal Mesothelioma
Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to disease progression or completion of therapy, patient's will be followed for survival, QOL assessments, and tumor assessments every 3 months (or as clinically indicated) for the first year and every 3 months thereafter for a maximum of 5 years.
Read the detailed description
The primary objective of this study is to determine the objective tumor response rate for VELCADE plus ELOXATIN in patients with malignant mesothelioma.
The aims of this study are to: (a)to determine the tumor response rate, median survival, time to response, duration of response and time to treatment failure or progression of disease;(b)to ascertain if in vitro assessment of gene expression profiles via PCR can be used to ascertain a patient's response to VELCADE (bortezomib) therapy (c) to characterize the quantitative and qualitative toxicities of VELCADE plus ELOXATIN in this patient population.
Each cycle of treatment is composed of 28 days and consists of four treatments with VELCADE (d 1,4,15,and 18) and two treatments with ELOXATIN (days 4,and 18). Patients will undergo a physical examination and routine blood work at each visit. A Quality of Life (QOL) assessment will be performed prior to initiating each cycle of therapy and CT scans will be performed at baseline and every 2 cycles (8 weeks)to assess tumor response.
- Conditions
- Mesothelioma
- Being tested
- Velcade (bortezomib) plus Eloxatin (oxaliplatin)
- Keywords
- Pleural Mesothelioma, Peritoneal Mesothelioma
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velcade (bortezomib) plus Eloxatin (oxaliplatin)Drug
Also called Velcade, Eloxatin
One cycle is defined as an interval of 28 days. A cycle is comprised of four treatments of Velcade (Bortezomib) 1.3 mg/m2 given on days 1, 14, 15, and 18 and two treatments of Eloxatin (Oxaliplatin) 85 mg/m2 on days 4 and 18.
| Study group | Role | What they receive |
|---|---|---|
| Velcade plus Eloxatin | Experimental | Six 20-day cycles Receives: Drug: Velcade (bortezomib) plus Eloxatin (oxaliplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response rate
Measured: Every 28 days post cycle treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert N Taub, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996385
- Sponsor's protocol ID
- AAAD4868
- Status last verified
- Oct 2011
- First submitted
- 14 Oct 2009
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Stage, Open Label, Phase II Study of VELCADE Plus ELOXATIN in Previously Treated Patients With Malignant Pleural or Peritoneal Mesothelioma
- ClinicalTrials.gov ID
- NCT00996385
- Acronym / sponsor ID
- AAAD4868
- Conditions
- Mesothelioma
- Keywords
- Pleural Mesothelioma, Peritoneal Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 16 Oct 2009 (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.
Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to disease progression or completion of therapy, patient's will be followed for survival, QOL assessments, and tumor assessments every 3 months (or as clinically indicated) for the first year and every 3 months thereafter for a maximum of 5 years.
Detailed description
The primary objective of this study is to determine the objective tumor response rate for VELCADE plus ELOXATIN in patients with malignant mesothelioma.
The aims of this study are to: (a)to determine the tumor response rate, median survival, time to response, duration of response and time to treatment failure or progression of disease;(b)to ascertain if in vitro assessment of gene expression profiles via PCR can be used to ascertain a patient's response to VELCADE (bortezomib) therapy (c) to characterize the quantitative and qualitative toxicities of VELCADE plus ELOXATIN in this patient population.
Each cycle of treatment is composed of 28 days and consists of four treatments with VELCADE (d 1,4,15,and 18) and two treatments with ELOXATIN (days 4,and 18). Patients will undergo a physical examination and routine blood work at each visit. A Quality of Life (QOL) assessment will be performed prior to initiating each cycle of therapy and CT scans will be performed at baseline and every 2 cycles (8 weeks)to assess tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velcade plus Eloxatin | Experimental | Drug: Velcade (bortezomib) plus Eloxatin (oxaliplatin)Six 20-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically confirmed malignant pleural or peritoneal mesothelioma epithelial, sarcomatoid, or mixed subtype, not amenable to curative treatment with surgery. Patients with pleural mesothelioma will be clinically staged using the IMIG's staging criteria (section 17.1). Note that there is no staging system for peritoneal mesothelioma and those patients will only be followed for survival. Patients may be entered based on local pathology.
- Patients must have had ≤2 prior form of systemic chemotherapy. Prior intracavitary chemotherapy will be considered a prior regimen unless it was given for the purpose of pleurodesis. Immunomodulators will not be regarded as chemotherapy. Prior systemic treatment with pemetrexed plus cisplatin or carboplatin will not be a contraindication for treatment with VELCADE/ELOXATIN.
- Disease status must be that of measurable disease as defined by modified SWOG criteria.
- Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology.
- Measurable lesions: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scans. At least one level must have one rind measurement ≥15 mm. CT (specifically spiral CT) scans and MRI are the preferred methods of measurement.
Key exclusion criteria (13 listed)
- Has active peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE; Version 3).
- Has experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality noted should be documented by the investigator as not medically relevant.
- Has been treated previously with VELCADE or ELOXATIN.
- Has had prior radiation therapy to the target lesion, unless the lesion is clearly progressing and the interval between the most recent radiation therapy and enrollment is at least 4 weeks.
- Has uncontrolled active systemic infection requiring therapy.
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 |
|---|---|---|
| Velcade (bortezomib) plus Eloxatin (oxaliplatin)Also: Velcade, EloxatinOne cycle is defined as an interval of 28 days. A cycle is comprised of four treatments of Velcade (Bortezomib) 1.3 mg/m2 given on days 1, 14, 15, and 18 and two treatments of Eloxatin (Oxaliplatin) 85 mg/m2 on days 4 and 18. | Drug | Velcade plus Eloxatin |
Primary outcome
Objective tumor response rate
Time frame: Every 28 days post cycle treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Irving Comprehensive Cancer Center Clinical Research Management Office contact
Robert N Taub, MD, PhD principal investigator
Columbia University
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 Velcade (bortezomib) plus Eloxatin (oxaliplatin) in people with Mesothelioma, run by Columbia University 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 15 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herbert Irving Comprehensive Cancer Center Clinical Research Management Office (212-305-8615), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response rate (time frame: Every 28 days post cycle treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2011.