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

NCT00086879 | Completed Phase 2

• 1 other identifier: EORTC-26034-16031
• Study Type: interventional
• Target: 110
• Locations: 5 countries
• Sites: 10

Brief 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 6 months

Secondary Outcomes (4)

• Response (complete [CR] or partial response [PR]) measured by McDonald's criteria at least 4 weeks after first documented response and every 8 weeks until disease progression or until start of another treatment

• Severe toxic events assessed by CTCAE v3.0 at the end of each course

• Progression-free survival at 1 year

• Overall survival at 6 months and 1 year

Interventions

carmustine DRUG

erlotinib hydrochloride DRUG

temozolomide DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (10)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, 2501 CK, Netherlands

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (2)

• van den Bent MJ, Brandes AA, Rampling R, Kouwenhoven MC, Kros JM, Carpentier AF, Clement PM, Frenay M, Campone M, Baurain JF, Armand JP, Taphoorn MJ, Tosoni A, Kletzl H, Klughammer B, Lacombe D, Gorlia T. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J Clin Oncol. 2009 Mar 10;27(8):1268-74. doi: 10.1200/JCO.2008.17.5984. Epub 2009 Feb 9.

  PMID: 19204207 RESULT

• van den Bent MJ, Brandes A, Rampling R, et al.: Randomized phase II trial of erlotinib (E) versus temozolomide (TMZ) or BCNU in recurrent glioblastoma multiforme (GBM): EORTC 26034. [Abstract] J Clin Oncol 25 (Suppl 18): A-2005, 2007.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Brain Neoplasms; Gliosarcoma

Interventions

Carmustine; Erlotinib Hydrochloride; Temozolomide

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; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Martin J. van Den Bent, MD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: May 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2011
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

GB (1); BE (1); NL (2); FR (5); IT (1)