Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068952
• Other study ID #: EDOAGL-8725-001
• Secondary ID: A5921009
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2003
• Last updated: March 27, 2008
• Start date: August 2003
• Est. completion date: March 2006

Study information

• Verified date: March 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• Edotecarin

• Temozolomide

• Carmustine (BCNU)

• Lomustine (CCNU)

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Clayton
Australia	Pfizer Investigational Site	East Bentleigh	Victoria
Australia	Pfizer Investigational Site	St. Leonards	New South Wales
Austria	Pfizer Investigational Site	Graz
Austria	Pfizer Investigational Site	Wien
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Moncton	New Brunswick
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Croatia	Pfizer Investigational Site	Split
Croatia	Pfizer Investigational Site	Zagreb
Czech Republic	Pfizer Investigational Site	Hradec Kralove
Czech Republic	Pfizer Investigational Site	Praha 5
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Nantes St. Herblain
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Regensburg
Germany	Pfizer Investigational Site	Tuebingen
India	Pfizer Investigational Site	Bangalore
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Padova
Russian Federation	Pfizer Investigational Site	Moscow
Singapore	Pfizer Investigational Site	Unknown
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Pretoria
Spain	Pfizer Investigational Site	Badalona
Spain	Pfizer Investigational Site	Hospitalet de Llobregat
Spain	Pfizer Investigational Site	Oviedo
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Edgewood	Kentucky
United States	Pfizer Investigational Site	Edgweood	Kentucky
United States	Pfizer Investigational Site	Edison	New Jersey
United States	Pfizer Investigational Site	Evanston	Illinois
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Croatia,  Czech Republic,  France,  Germany,  India,  Italy,  Russian Federation,  Singapore,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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