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Enzastaurin and Temozolomide in Treating Patients With Primary Gliomas

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ClinicalTrials.gov Identifier: NCT00516607
Recruitment Status : Unknown
Verified February 2015 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2007
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE August 14, 2007
First Posted Date  ICMJE August 15, 2007
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
  • Recommended phase II dose
  • Dose-limiting toxicity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
  • Response rate
  • Progression-free survival
  • Overall survival
  • Pharmacokinetics of enzastaurin hydrochloride alone and in combination with temozolomide
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enzastaurin and Temozolomide in Treating Patients With Primary Gliomas
Official Title  ICMJE Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas
Brief Summary

RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving enzastaurin together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin when given together with temozolomide in treating patients with primary gliomas.

Detailed Description

OBJECTIVES:

  • To assess if full doses of enzastaurin hydrochloride and temozolomide can be used in combination for the treatment of patients with primary gliomas.
  • To determine the recommended phase II dose.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride once or twice daily on days 1-28* and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *During the first course only, patients also receive enzastaurin hydrochloride on day -1.

Patients undergo blood sample collection on day 22 of course 1 and on day 5 of course 2 for pharmacokinetic studies of enzastaurin hydrochloride.

After completion of study treatment, patients are followed within 30 days and then every 3 months thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: enzastaurin hydrochloride
  • Drug: temozolomide
  • Other: pharmacological study
Study Arms  ICMJE Not Provided
Publications * Rampling R, Sanson M, Gorlia T, Lacombe D, Lai C, Gharib M, Taal W, Stoffregen C, Decker R, van den Bent MJ. A phase I study of LY317615 (enzastaurin) and temozolomide in patients with gliomas (EORTC trial 26054). Neuro Oncol. 2012 Mar;14(3):344-50. doi: 10.1093/neuonc/nor221. Epub 2012 Jan 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 20, 2013)
28
Original Enrollment  ICMJE
 (submitted: August 14, 2007)
40
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary supratentorial glioma

    • WHO histologic grade 3 or 4

      • Patients who have undergone prior treatment for low-grade glioma that has transformed to glioblastoma (biopsy proven) allowed
  • Amenable to standard temozolomide treatment
  • First or second recurrent disease after prior surgery and/or radiotherapy OR newly diagnosed disease that is not amenable to radiotherapy (e.g., multifocal disease)

PATIENT CHARACTERISTICS:

  • ECOG or WHO performance status 0-2
  • Hemoglobin ≥ 10.0 g/dL
  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Alkaline phosphatase and transaminases ≤ 2.5 x ULN
  • Serum creatinine < 1.7 mg/dL
  • Not pregnant or lactating
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Clinically normal cardiac function
  • No ischemic heart disease within the past 6 months
  • No clinically significant abnormalities or uncontrolled cardiac arrhythmia by ECG
  • QTc interval ≤ 450 msec (males) or ≤ 470 msec (females) by baseline 12-lead ECG
  • No history of congenital long QTc syndrome
  • No history of stroke
  • No other prior or concurrent malignancy within the past 5 years except cone biopsied carcinoma of the cervix or adequately treated basal or squamous cell skin carcinoma
  • No unstable systemic diseases
  • No active uncontrolled infections
  • No uncontrolled hypertension
  • No psychological, familial, sociological, or geographical condition that would preclude study participation
  • Must be able to swallow tablets

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen in the adjuvant setting or for first recurrence
  • Prior temozolomide allowed provided there was no disease progression during temozolomide treatment or within 6 weeks of completing temozolomide treatment
  • Prior surgery for primary brain tumor within the past 3 months allowed
  • Patients who are receiving corticosteroid treatment must be on a stable or decreasing dose for at least 1 week before study entry
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 14 days since prior and no concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following:

    • Phenytoin
    • Carbamazepine
    • Phenobarbital
  • More than 30 days since prior and no other concurrent investigational treatments
  • No concurrent anticoagulant treatment (e.g., warfarin)

    • Low molecular weight heparin for patients who require anticoagulant therapy after starting study treatment may be allowed
  • No concurrent routine use of colony-stimulating factors
  • No other concurrent anticancer agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00516607
Other Study ID Numbers  ICMJE EORTC-26054
EORTC-26054
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roy Rampling, MD, PhD University of Glasgow
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP