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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glioblastoma

Intervention: Edotecarin (Drug); Temozolomide (Drug); Carmustine (BCNU) (Drug); Lomustine (CCNU) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Clayton, Australia

Pfizer Investigational Site, Graz, Austria

Pfizer Investigational Site, Wien, Austria

Pfizer Investigational Site, Split, Croatia

Pfizer Investigational Site, Zagreb, Croatia

Pfizer Investigational Site, Hradec Kralove, Czech Republic

Pfizer Investigational Site, Praha 5, Czech Republic

Pfizer Investigational Site, Lyon, France

Pfizer Investigational Site, Nantes St. Herblain, France

Pfizer Investigational Site, Berlin, Germany

Pfizer Investigational Site, Mainz, Germany

Pfizer Investigational Site, Regensburg, Germany

Pfizer Investigational Site, Tuebingen, Germany

Pfizer Investigational Site, Bangalore, India

Pfizer Investigational Site, Bologna, Italy

Pfizer Investigational Site, Padova, Italy

Pfizer Investigational Site, Moscow, Russian Federation

Pfizer Investigational Site, Unknown, Singapore

Pfizer Investigational Site, Cape Town, South Africa

Pfizer Investigational Site, Pretoria, South Africa

Pfizer Investigational Site, Badalona, Spain

Pfizer Investigational Site, Hospitalet de Llobregat, Spain

Pfizer Investigational Site, Oviedo, Spain

Pfizer Investigational Site, Calgary, Alberta, Canada

Pfizer Investigational Site, Phoenix, Arizona, United States

Pfizer Investigational Site, Little Rock, Arkansas, United States

Pfizer Investigational Site, Vancouver, British Columbia, Canada

Pfizer Investigational Site, New Haven, Connecticut, United States

Pfizer Investigational Site, Orlando, Florida, United States

Pfizer Investigational Site, Atlanta, Georgia, United States

Pfizer Investigational Site, Chicago, Illinois, United States

Pfizer Investigational Site, Evanston, Illinois, United States

Pfizer Investigational Site, Edgewood, Kentucky, United States

Pfizer Investigational Site, Edgweood, Kentucky, United States

Pfizer Investigational Site, Lexington, Kentucky, United States

Pfizer Investigational Site, Winnipeg, Manitoba, Canada

Pfizer Investigational Site, Boston, Massachusetts, United States

Pfizer Investigational Site, Moncton, New Brunswick, Canada

Pfizer Investigational Site, Lebanon, New Hampshire, United States

Pfizer Investigational Site, Edison, New Jersey, United States

Pfizer Investigational Site, Summit, New Jersey, United States

Pfizer Investigational Site, St. Leonards, New South Wales, Australia

Pfizer Investigational Site, Halifax, Nova Scotia, Canada

Pfizer Investigational Site, Cincinnati, Ohio, United States

Pfizer Investigational Site, Hamilton, Ontario, Canada

Pfizer Investigational Site, Ottawa, Ontario, Canada

Pfizer Investigational Site, Toronto, Ontario, Canada

Pfizer Investigational Site, Philadelphia, Pennsylvania, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania, United States

Pfizer Investigational Site, Dallas, Texas, United States

Pfizer Investigational Site, East Bentleigh, Victoria, Australia

Pfizer Investigational Site, Charlottesville, Virginia, United States

Additional Information

Starting date: August 2003
Last updated: March 27, 2008

Page last updated: August 23, 2015

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