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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

erlotinib hydrochloride

temozolomide

radiation therapy

About this trial

This is an interventional treatment trial for CNS Tumor, Adult focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy, Temozolomide, and Erlotinib

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Progression Free Survival

Number of patients that experience toxicity (CTCAE V2)

Overall Survival

Full Information

NCT ID

NCT00274833

First Posted

January 10, 2006

Last Updated

December 5, 2012

Sponsor

David Peereboom

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00274833

Brief Title

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

Official Title

A Phase II Trial of Erlotinib With Temozolomide and Concurrent Radiation Therapy Post-Operatively in Patients With Newly Diagnosed Glioblastoma Multiforme

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David Peereboom

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CNS Tumor, Adult

Keywords

adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiation Therapy, Temozolomide, and Erlotinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

erlotinib hydrochloride

Other Intervention Name(s)

Tarceva

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

temozolomide

Other Intervention Name(s)

Temodar

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Other Intervention Name(s)

RT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

at 6 months

Secondary Outcome Measure Information:

Title

Progression Free Survival

Time Frame

at 1 yr

Title

Number of patients that experience toxicity (CTCAE V2)

Time Frame

at 6 months

Title

Overall Survival

Time Frame

date of final follow up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M. Peereboom, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

CNS Tumor, Adult

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial