Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme.

PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Carmustine; Dacarbazine; Erlotinib Hydrochloride; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed glioblastoma multiforme

• Some oligodendroglial elements allowed provided they make up < 25% of the tumor

• Recurrent disease documented by MRI after prior radiotherapy

• At least 1 bidimensionally measurable target lesion ≥ 2 cm by MRI

• Undergone prior surgery for recurrent primary brain tumor more than 3 months before study entry

• Must have a clearly limited target lesion ≥ 2 cm OR evidence of progressive and measurable target lesion OR a second measurable target lesion outside the surgical area

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm ^3

Hepatic

• AST and ALT < 2.5 times upper limit of normal (ULN)

• Bilirubin < 1.5 times ULN

Renal

• Creatinine < 1.5 times ULN

Cardiovascular

• Clinically normal cardiac function

• No ischemic heart disease within the past 12 months

• No New York Heart Association grade III or IV cardiac insufficiency

• No unstable angina

• No arryhthmia

Pulmonary

• DLCO > 70% of predicted (for patients randomized to receive erlotinib [arm I] or carmustine [arm II])

• No history of pulmonary disease that would affect pulmonary function including any of the following:

• Chronic bronchopneumopathy

• Pleural effusion

• Interstitial pnuemonia

• Pulmonary lymphangitis

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No other malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer

• No psychological, familial, sociological, or geographical factors that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior HER-targeted agents

• No concurrent growth factors for neutrophil count elevation

• No concurrent epoetin alfa

Chemotherapy

• Prior adjuvant temozolomide allowed

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No more than 1 prior adjuvant chemotherapy regimen

• No prior chemotherapy for recurrent disease

Endocrine therapy

• Must be on a stable or decreasing dose of corticosteroids for at least 2 weeks before study entry

Radiotherapy

• See Disease Characteristics

• More than 3 months since prior radiotherapy to the brain

• No prior high-dose radiotherapy (> 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless disease recurrence confirmed

Surgery

• See Disease Characteristics

Other

• No prior participation in experimental therapies

• No concurrent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, troleandomycin, cimetidine, or grapefruit juice)

• No concurrent warfarin or other coumarin derivatives

• Concurrent low-molecular weight heparin allowed

• No other concurrent investigational drugs