Malignant Pleural MesotheliomaPhase 1/2N08CPANCT01211275
Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma
A Phase 1/2 study testing axitinib and chemotherapy in people with Malignant Pleural Mesothelioma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- axitinib and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 May 2009to 6 May 2013
- 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
- histologically or cytologically diagnosed malignant mesothelioma
- age > 18 years
- Medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy)
- Measurable or evaluable disease is not required
- Ability to understand the study and give signed informed consent including the approval to accept a second thoracoscopic or surgical treatment after the third course
- No previous chemotherapy
Show all 18Show fewer
- Radiotherapy is allowed when this is given for palliation, the interval is > 4 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field.
- WHO performance status =< 2
- Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
- Hematology:
- ANC=>1.5 x 109/L,
- Platelets=>150 x 109/L,
- Hemoglobin => 6,0 mmol/l
- Chemistry:
- total serum bilirubin < UNL;
- AST and ALT= < 2.5xUNL,
- AP < 5xUNL (unless bone metastases are present in the absence or any liver disease)
- Serum creatinine =< 2xUNL
Who cannot join
- Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency
- Previous successful pleurodesis
- Uncontrolled hypertension
- Symptomatic peripheral neuropathy => grade 2 according to NCIC CTC,version 3.0
- Presence of symptomatic CNS metastases
- Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition
- Concomitant administration to any other experimental drugs under investigation
- Impaired renal function
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Antoni van Leeuwenhoekziekenhuis (NKI-AVL)
Amsterdam, North Holland, 1066 CX
About this study
Official title: A Randomized Phase I/II Study of Standard Chemotherapy (Cisplatin and Pemetrexed) With or Without Axitinib in Patients With Malignant Mesothelioma: Interim Biopsy Analysis to Determine Efficacy
The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma
Read the detailed description
To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD): expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis.
To determine the safety of the addition of axitinib (to a maximum of the recommended dose of maximally 2 x 10 mg per day) to the standard treatment with cisplatin and pemetrexed.
To determine the feasibility of performing a (second) thoracoscopy after 10 weeks of the combination treatment with cisplatin, pemetrexed and axitinib.
Serum samples will be collected and tested for inhibiting effects in a tube formation and spheroid sprouting assay.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- axitinib, chemotherapy
- Keywords
- mesothelioma, chemotherapy, translational research, axitinib
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axitinibBiological
Also called cisplatin, alimta
axitinib: 5 mg BID, day 2 until day 21 of each cycle; cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
chemotherapyDrug
Also called cisplatin, alimta
cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| arm 2 | Experimental | axitinib + cisplatin + premetrexed Receives: Biological: axitinib |
| arm 1 | Active comparator | cisplatin + premetrexed Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples
To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD); expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis
Measured: micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis
Secondary outcomes (1)
the side effects of the standard chemotherapy and the additional risks related to axitinib use
hypertension, fatigue, abdominal discomfort
Measured: AE;SAE;SUSAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study start22 May 2009
- Primary completion13 Nov 2012
- Study completion6 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- P Baas, Dr., Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211275
- Sponsor's protocol ID
- NL25655.031.08
- Acronym
- N08CPA
- Status last verified
- Feb 2017
- First submitted
- 27 Sep 2010
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Study of Standard Chemotherapy (Cisplatin and Pemetrexed) With or Without Axitinib in Patients With Malignant Mesothelioma: Interim Biopsy Analysis to Determine Efficacy
- ClinicalTrials.gov ID
- NCT01211275
- Acronym / sponsor ID
- N08CPA / NL25655.031.08
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- mesothelioma, chemotherapy, translational research, axitinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 22 May 2009 (actual)
- Primary completion
- 13 Nov 2012 (actual)
- Study completion
- 6 May 2013 (actual)
- First posted
- 29 Sep 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.
The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma
Detailed description
To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD): expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis.
To determine the safety of the addition of axitinib (to a maximum of the recommended dose of maximally 2 x 10 mg per day) to the standard treatment with cisplatin and pemetrexed.
To determine the feasibility of performing a (second) thoracoscopy after 10 weeks of the combination treatment with cisplatin, pemetrexed and axitinib.
Serum samples will be collected and tested for inhibiting effects in a tube formation and spheroid sprouting assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 2 | Experimental | Biological: axitinibaxitinib + cisplatin + premetrexed |
| arm 1 | Active comparator | Drug: chemotherapycisplatin + premetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- histologically or cytologically diagnosed malignant mesothelioma
- age > 18 years
- Medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy)
- Measurable or evaluable disease is not required
- Ability to understand the study and give signed informed consent including the approval to accept a second thoracoscopic or surgical treatment after the third course
Key exclusion criteria (8 listed)
- Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency
- Previous successful pleurodesis
- Uncontrolled hypertension
- Symptomatic peripheral neuropathy => grade 2 according to NCIC CTC,version 3.0
- Presence of symptomatic CNS metastases
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 |
|---|---|---|
| axitinibAlso: cisplatin, alimtaaxitinib: 5 mg BID, day 2 until day 21 of each cycle; cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks. | Biological | arm 2 |
| chemotherapyAlso: cisplatin, alimtacisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks. | Drug | arm 1 |
Primary outcome
To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples
Time frame: micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis
To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD); expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis
1 secondary outcome
the side effects of the standard chemotherapy and the additional risks related to axitinib use
Time frame: AE;SAE;SUSAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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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.
P Baas, Dr. principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing axitinib and chemotherapy in people with Malignant Pleural Mesothelioma, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 18 inclusion and 8 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 28 Feb 2017. 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 Netherlands. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples (time frame: micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis). 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 28 Feb 2017.