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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00068952




Registration number
NCT00068952
Ethics application status
Date submitted
12/09/2003
Date registered
16/09/2003
Date last updated
1/04/2008

Titles & IDs
Public title
Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
Scientific 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
Secondary ID [1] 0 0
A5921009
Secondary ID [2] 0 0
EDOAGL-8725-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Edotecarin
Treatment: Drugs - Temozolomide
Treatment: Drugs - Carmustine (BCNU)
Treatment: Drugs - Lomustine (CCNU)

Treatment: Drugs: Edotecarin


Treatment: Drugs: Temozolomide


Treatment: Drugs: Carmustine (BCNU)


Treatment: Drugs: Lomustine (CCNU)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- 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

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [2] 0 0
Pfizer Investigational Site - East Bentleigh
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Clayton
Recruitment postcode(s) [1] 0 0
- St. Leonards
Recruitment postcode(s) [2] 0 0
- East Bentleigh
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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United States of America
State/province [4] 0 0
Florida
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United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
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United States of America
State/province [7] 0 0
Kentucky
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United States of America
State/province [8] 0 0
Massachusetts
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Manitoba
Country [20] 0 0
Canada
State/province [20] 0 0
New Brunswick
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Croatia
State/province [23] 0 0
Split
Country [24] 0 0
Croatia
State/province [24] 0 0
Zagreb
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Hradec Kralove
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Czech Republic
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Praha 5
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France
State/province [27] 0 0
Lyon
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France
State/province [28] 0 0
Nantes St. Herblain
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
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Germany
State/province [30] 0 0
Mainz
Country [31] 0 0
Germany
State/province [31] 0 0
Regensburg
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Germany
State/province [32] 0 0
Tuebingen
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India
State/province [33] 0 0
Bangalore
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Italy
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Bologna
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Italy
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Padova
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Russian Federation
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Moscow
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South Africa
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Cape Town
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South Africa
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Pretoria
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Spain
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Badalona
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Spain
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Hospitalet de Llobregat
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Spain
State/province [41] 0 0
Oviedo
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State/province [42] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00068952
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00068952