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

NCT00274833 | Completed Phase 2 DMC

• 3 other identifiers: CASE3304P30CA043703CCF-6320
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

CNS Tumor, Adult

Keywords

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  at 6 months

Secondary Outcomes (3)

• Progression Free Survival

  at 1 yr

• Number of patients that experience toxicity (CTCAE V2)

  at 6 months

• Overall Survival

  date of final follow up visit

Study Arms (1)

Radiation Therapy, Temozolomide, and Erlotinib

EXPERIMENTAL

Drug: erlotinib hydrochloride; Drug: temozolomide; Radiation: radiation therapy

Interventions

erlotinib hydrochloride DRUG

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.

Also known as: Tarceva

Radiation Therapy, Temozolomide, and Erlotinib

temozolomide DRUG

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.

Also known as: Temodar

Radiation Therapy, Temozolomide, and Erlotinib

radiation therapy RADIATION

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.

Also known as: RT

Radiation Therapy, Temozolomide, and Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• David Peereboom: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Erlotinib Hydrochloride; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• David M. Peereboom, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: October 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: September 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

US (1)