Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Peereboom, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00274833
First received: January 10, 2006
Last updated: December 5, 2012
Last verified: December 2012

January 10, 2006
December 5, 2012
October 2005
October 2007   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00274833 on ClinicalTrials.gov Archive Site
  • Progression Free Survival [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
  • Number of patients that experience toxicity (CTCAE V2) [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: date of final follow up visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase II Trial of Erlotinib With Temozolomide and Concurrent Radiation Therapy Post-Operatively in Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with temozolomide and erlotinib after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide and erlotinib works in treating patients with newly diagnosed glioblastoma multiforme.

OBJECTIVES:

  • Determine the progression-free survival and overall survival of patients with newly diagnosed glioblastoma multiforme treated with adjuvant radiotherapy, temozolomide, and erlotinib hydrochloride.
  • Evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized study.

Patients receive oral temozolomide once daily on days 1-42 and undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Four weeks after completion of radiotherapy and temozolomide, patients receive oral temozolomide once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral erlotinib hydrochloride once daily beginning on day 1 of radiotherapy and continuing in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
CNS Tumor, Adult
  • Drug: erlotinib hydrochloride
    Erlotinib is available as 25 mg, 100 mg, and 150 mg tablets. It should be administered orally once daily at the prescribed dose specified in the clinical study protocol per dose escalation schema. Preferably, erlotinib should be taken in the morning with up to 200 mL of water at least 1 hour before or 2 hours after a meal.
    Other Name: Tarceva
  • Drug: temozolomide
    TMZ is supplied in white opaque, preservative-free, two piece hard gelatin capsules of the following sizes: 100mg capsules, 20mg capsules, and 5mg capsules. TMZ will be a once a day orally administered (75 mg/m2 x BSA x 42 days)set of capsules taken at least two hours after and one hour before a meal.
    Other Name: Temodar
  • Radiation: radiation therapy
    Concomitant focal RT will be delivered once daily at 2 Gy per fraction, 5 d/wk, for a total of 60 Gy. (6 weeks) as mentioned in therapeutic modalities.
    Other Name: RT
Experimental: Radiation Therapy, Temozolomide, and Erlotinib
Interventions:
  • Drug: erlotinib hydrochloride
  • Drug: temozolomide
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
September 2012
October 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven glioblastoma multiforme

    • Newly diagnosed disease
  • Has undergone diagnostic biopsy or surgical resection within the past 28 days

PATIENT CHARACTERISTICS:

  • ECOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 9 g/L
  • Serum creatinine and total serum bilirubin < 1.5 times upper limit of normal (ULN)
  • AST or ALT < 2.5 times ULN
  • Alkaline phosphatase < 2.5 times ULN
  • No other severe underlying disease (including HIV or chronic hepatitis B or C infection)
  • Fertile patients must use effective contraception
  • Not pregnant or nursing
  • No medical condition that could interfere with the oral administration of temozolomide or erlotinib hydrochloride
  • No other malignancy within the past 3 years with the exception of surgically cured carcinoma in situ of the cervix, nonmelanoma skin cancer, or adequately treated stage I or II cancer from which the patient is in complete remission
  • No active infection
  • No other condition that would preclude ability of the patient to be followed closely at the Cleveland Clinic

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or chemotherapy for this cancer
  • No prior cranial radiotherapy
  • No concurrent enzyme-inducing anti-epileptic drugs
  • No prior temozolomide or erlotinib hydrochloride
  • No other concurrent antineoplastic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) during chemotherapy
  • No concurrent electron, particle, or implant boost radiotherapy
  • No concurrent radiosurgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00274833
CASE3304, P30CA043703, CASE3304, CCF-6320
Yes
David Peereboom, Case Comprehensive Cancer Center
David Peereboom
National Cancer Institute (NCI)
Study Chair: David M. Peereboom, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
December 2012

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