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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00086879
• Date of registration: 08/07/2004
• Prospective Registration: No
• Primary sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Public title: Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme
• Scientific title: Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme
• Date of first enrolment: May 2004
• Target sample size: 110
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00086879
• Study type: Interventional
• Study design: Allocation: Randomized. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Italy, Netherlands, United Kingdom

Contacts

• Name: Martin J. van Den Bent, MD
• Affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 120 Years
Gender: All

Health Condition(s) or Problem(s) studied

Brain and Central Nervous System Tumors

Intervention(s)

Drug: erlotinib hydrochloride

Drug: temozolomide

Drug: carmustine

Primary Outcome(s)

Progression-free survival at 6 months

Secondary Outcome(s)

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

Progression-free survival at 1 year

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

Overall survival at 6 months and 1 year

Secondary ID(s)

EORTC-26034-16031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors