GlioblastomaPhase 3NCT00068952
Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
A Phase 3 study testing Edotecarin, Temozolomide and Carmustine (BCNU) in people with Glioblastoma, run by Pfizer at 52 sites in 14 countries.
Trial summary
The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Edotecarin, Temozolomide and Carmustine (BCNU)
- How many people
- 118 participants
- Where
- 52 sitesin 14 countries
- Study dates
- Aug 2003to Mar 2006
- Phase
- Phase 3
- 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
- Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy)
- Must have past biopsy samples available for central pathology review
- Must have evidence on Gd-MRI of progressive/recurrent disease
- Must have measurable disease on Gd-MRI obtained within 14 days prior to start of study treatment
- Must be at least 18 years of age
- Must have a Karnofsky Performance Status score of at least 70
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- If being treated with steroids, the steroid dose must be stable or decreasing for 1 week prior to randomization
- If being treated with anticonvulsants, must have no change in the type of anticonvulsants for 2 weeks prior to randomization
- All acute toxic effects (except for alopecia) of any prior treatment must have resolved or are no greater than grade 1 (NCI Common Toxicity Criteria, Version 2.0)
- Baseline laboratory data must be within the following limits: absolute neutrophil count at least 1500; platelets at least 100,000; hemoglobin at least 9.0 g/dL; serum creatinine no greater than 1.5 mg/dL, total serum bilirubin no greater than 1.5 times the upper limit of the normal range; SGOT and SGPT no greater than 2.5 times the upper limit of the normal range; albumin at least 3.0 g/dL, serum or urine pregnancy test (for females of childbearing potential) negative within 7 days prior to start of study treatment
- At least 6 weeks must have elapsed since completion of prior nitrosurea therapy; at least 4 weeks since completion of prior temozolomide therapy
- Must have written informed consent
- Must be able and willing to comply with study procedures
- \	Must have received prior treatment with radiotherapy (conventional fractionated external beam) and (neo)adjuvant/concurrent chemotherapy (with a temozolomide- or a nitrosurea-based containing )regimen for GBM
Who cannot join
- Must not have received prior treatment (except for surgical debulking) of first relapse (progression or recurrence) of GBM
- Must not have received prior treatment with another topoisomerase-I inhibitor (e.g. irinotecan, topotecan, rubitecan)
- Must not have had radiosurgery or radiotherapy within 1 month prior to randomization
- Must not have had prior brachytherapy or chemotherapy wafer implantation
- Must not have had prior high-dose chemotherapy with bone marrow or stem cell support
- Must not receive concomitant treatment with any other investigational agent or anti-cancer treatment during the study
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- Must not be currently enrolled in another therapeutic clinical trial for the treatment of GBM
- Must not currently (or in the past 5 years) have other malignancies (except for adequately treated basal cell or squamous cell skin cancer or non-invasive cervical cancer)
- Must not have any of the following in the past 6 months: myocardial infarction (heart attack), severe/unstable angina, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (stroke), or transient ischemic attack (TIA)
- Must not have had any of the following in the past 2 months: pulmonary embolus (blood clot in lungs), deep venous thrombosis (blood clot in veins), or other significant thromboembolic event
- Must not have an ongoing cardiac dysrhythmia (abnormal heart rhythm) of grade 2 or higher (NCI Common Toxicity Criteria, Version 2.0)
- Must not have known human immunodeficiency virus (HIV) infection
- Must not be pregnant or breastfeeding. Patients (male and female) must be surgically sterile (or postmenopausal for females) or must agree to use effective contraception during the period of study treatment
- Must not be inappropriate for entry into the study, in the judgment of the investigator
Trial locations and contacts
52 sites in 14 countries.
52 sites in 14 countries
United States19 sites
Pfizer Investigational Site
Atlanta, Georgia
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Charlottesville, Virginia
Pfizer Investigational Site
Chicago, Illinois
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Edgewood, Kentucky
Pfizer Investigational Site
Edgweood, Kentucky
Pfizer Investigational Site
Edison, New Jersey
Pfizer Investigational Site
Evanston, Illinois
Pfizer Investigational Site
Lebanon, New Hampshire
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
New Haven, Connecticut
Pfizer Investigational Site
Orlando, Florida
Pfizer Investigational Site
Philadelphia, Pennsylvania
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Pittsburgh, Pennsylvania
Pfizer Investigational Site
Summit, New Jersey
Canada8 sites
Pfizer Investigational Site
Calgary, Alberta
Pfizer Investigational Site
Halifax, Nova Scotia
Pfizer Investigational Site
Hamilton, Ontario
Pfizer Investigational Site
Moncton, New Brunswick
Pfizer Investigational Site
Ottawa, Ontario
Pfizer Investigational Site
Toronto, Ontario
Pfizer Investigational Site
Vancouver, British Columbia
Pfizer Investigational Site
Winnipeg, Manitoba
Germany4 sites
Pfizer Investigational Site
Berlin
Pfizer Investigational Site
Mainz
Pfizer Investigational Site
Regensburg
Pfizer Investigational Site
Tübingen
Australia3 sites
Pfizer Investigational Site
Clayton
Pfizer Investigational Site
East Bentleigh, Victoria
Pfizer Investigational Site
St Leonards, New South Wales
Spain3 sites
Pfizer Investigational Site
Badalona
Pfizer Investigational Site
L'Hospitalet de Llobregat
Pfizer Investigational Site
Oviedo
Austria2 sites
Pfizer Investigational Site
Graz
Pfizer Investigational Site
Vienna
Croatia2 sites
Pfizer Investigational Site
Split
Pfizer Investigational Site
Zagreb
Czechia2 sites
Pfizer Investigational Site
Hradec Králové
Pfizer Investigational Site
Prague
France2 sites
Pfizer Investigational Site
Lyon
Pfizer Investigational Site
Nantes Saint Herblain
Italy2 sites
Pfizer Investigational Site
Bologna
Pfizer Investigational Site
Padova
South Africa2 sites
Pfizer Investigational Site
Cape Town
Pfizer Investigational Site
Pretoria
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy
The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.
- Conditions
- Glioblastoma
- Being tested
- Edotecarin, Temozolomide, Carmustine (BCNU), Lomustine (CCNU)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdotecarinDrug
TemozolomideDrug
Carmustine (BCNU)Drug
Lomustine (CCNU)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the overall survival associated with edotecarin versus that associated with temozolomide or BCNU or CCNU for the treatment of patients with GBM at first relapse previously treated with alkylator-based (neo)adjuvant therapy
Secondary outcomes (1)
To assess measures of tumor control To evaluate measures of clinical benefit To assess the safety profile of edotecarin To assess the PK profile of edotecarin and the potential for drug interactions between anticonvulsants and edotecarin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2003 (estimated)
- Study startAug 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068952
- Sponsor's protocol ID
- EDOAGL-8725-001
- Other IDs
- A5921009
- Status last verified
- Mar 2008
- First submitted
- 12 Sep 2003
- Last updated
- 1 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT00068952
- Acronym / sponsor ID
- EDOAGL-8725-001
- Conditions
- Glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Mar 2006
- First posted
- 16 Sep 2003 (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 clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy)
- Must have past biopsy samples available for central pathology review
- Must have evidence on Gd-MRI of progressive/recurrent disease
- Must have measurable disease on Gd-MRI obtained within 14 days prior to start of study treatment
- Must be at least 18 years of age
Key exclusion criteria (14 listed)
- Must not have received prior treatment (except for surgical debulking) of first relapse (progression or recurrence) of GBM
- Must not have received prior treatment with another topoisomerase-I inhibitor (e.g. irinotecan, topotecan, rubitecan)
- Must not have had radiosurgery or radiotherapy within 1 month prior to randomization
- Must not have had prior brachytherapy or chemotherapy wafer implantation
- Must not have had prior high-dose chemotherapy with bone marrow or stem cell support
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 |
|---|---|---|
| Edotecarin | Drug | – |
| Temozolomide | Drug | – |
| Carmustine (BCNU) | Drug | – |
| Lomustine (CCNU) | Drug | – |
Primary outcome
To compare the overall survival associated with edotecarin versus that associated with temozolomide or BCNU or CCNU for the treatment of patients with GBM at first relapse previously treated with alkylator-based (neo)adjuvant therapy
1 secondary outcome
To assess measures of tumor control To evaluate measures of clinical benefit To assess the safety profile of edotecarin To assess the PK profile of edotecarin and the potential for drug interactions between anticonvulsants and edotecarin
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 1 Apr 2008.
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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.
Pfizer CT.gov Call Center study director
Pfizer
52 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Edotecarin, Temozolomide and Carmustine (BCNU) in people with Glioblastoma, run by Pfizer at 52 sites in 14 countries.
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 14 inclusion and 14 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 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Canada, Germany, Australia, Spain and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 compare the overall survival associated with edotecarin versus that associated with temozolomide or BCNU or CCNU for the treatment of patients with GBM at first relapse previously treated with alkylator-based (neo)adjuvant therapy. 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 1 Apr 2008.