Clinical trial · Interventional
Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme
Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme
NCT00086879CI-TRIAL-00028801completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival at 6 months
Secondary outcomes (4)
- measure
- 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
- measure
- Severe toxic events assessed by CTCAE v3.0 at the end of each course
- measure
- Progression-free survival at 1 year
- measure
- Overall survival at 6 months and 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTvan 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
- RESULTvan 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.