Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

erlotinib hydrochloride

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme Radiographic evidence of recurrence or progression Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal ALT no greater than 3 times normal Renal BUN no greater than 1.5 times normal OR Creatinine no greater than 1.5 times normal Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No medical condition that would interfere with oral administration of erlotinib No other medical or psychiatric illness that would preclude study therapy No active infection No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy for brain cancer No concurrent biologic therapy for brain cancer Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent chemotherapy for brain cancer Endocrine therapy Concurrent glucocorticosteroids allowed No concurrent hormonal therapy for brain cancer Radiotherapy See Disease Characteristics Surgery Not specified Other No prior epidermal growth factor receptor (EGFR) inhibitor No concurrent EGFR inhibitor No other concurrent antineoplastic therapy No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following: Gabapentin Lamotrigine Divalproex Felbamate Levetiracetam Tiagabine Topiramate Zonisamide

Sites / Locations

Cleveland Clinic Taussig Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Progression-free survival

Overall survival

Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling

Efficacy of tumor EGFR amplification in predicting response to treatment

Full Information

NCT ID

NCT00054496

First Posted

February 5, 2003

Last Updated

January 9, 2014

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00054496

Brief Title

Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

Official Title

Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Unknown status

Study Start Date

August 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

The Cleveland Clinic

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.

Detailed Description

OBJECTIVES: Determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib. Determine the progression-free and overall survival of patients treated with this drug. OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 73 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

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

73 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

erlotinib hydrochloride

Primary Outcome Measure Information:

Title

Response rate

Secondary Outcome Measure Information:

Title

Progression-free survival

Title

Overall survival

Title

Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling

Title

Efficacy of tumor EGFR amplification in predicting response to treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme Radiographic evidence of recurrence or progression Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal ALT no greater than 3 times normal Renal BUN no greater than 1.5 times normal OR Creatinine no greater than 1.5 times normal Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No medical condition that would interfere with oral administration of erlotinib No other medical or psychiatric illness that would preclude study therapy No active infection No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy for brain cancer No concurrent biologic therapy for brain cancer Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent chemotherapy for brain cancer Endocrine therapy Concurrent glucocorticosteroids allowed No concurrent hormonal therapy for brain cancer Radiotherapy See Disease Characteristics Surgery Not specified Other No prior epidermal growth factor receptor (EGFR) inhibitor No concurrent EGFR inhibitor No other concurrent antineoplastic therapy No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following: Gabapentin Lamotrigine Divalproex Felbamate Levetiracetam Tiagabine Topiramate Zonisamide

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A. Vogelbaum, MD, PhD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

Phone

866-223-8100

Brain and Central Nervous System Tumors

About this trial

Eligibility Criteria

Sites / Locations

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