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A Phase I/II Study of OSI-774 and Temozolomide In Combination With Radiation Therapy In Glioblastoma Multiforme

Phase 2
18 Years
Open (Enrolling)
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

Thank you

Trial Information

A Phase I/II Study of OSI-774 and Temozolomide In Combination With Radiation Therapy In Glioblastoma Multiforme


I. Determine the maximum tolerated dose of erlotinib administered with temozolomide and
radiotherapy in patients with glioblastoma multiforme or other grade 4 brain tumors who are
currently on enzyme-inducing anticonvulsant (EIAC) therapy vs no EIAC therapy.

II. Determine the safety and tolerability of this regimen in these patients. III. Determine
the toxic effects of this regimen in these patients. IV. Determine the efficacy of this
regimen, in terms of 1-year survival, in these patients.


I. Determine the response rate and time to progression in patients treated with this

II. Determine the 6-month progression-free survival of patients treated with this regimen.

III. Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation pilot study of erlotinib followed by a phase
II study. Patients are stratified according to concurrent enzyme-inducing anticonvulsant
drug use (yes vs no).

PILOT STUDY: Patients receive oral erlotinib once daily. After 1 week of erlotinib alone,
patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent
radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients continue
to receive erlotinib once daily alone in the absence of disease progression or unacceptable
toxicity. Beginning 4 weeks after the completion of radiotherapy, patients also receive oral
temozolomide once daily for 5 days. Temozolomide treatment repeats every 28 days for 6
courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.

PHASE II: Once the MTD of erlotinib is determined, additional patients are treated with
erlotinib at the MTD, temozolomide, and radiotherapy as above.

Patients are followed every 3 months for 5 years and then annually for 10 years.

Inclusion Criteria:

- Histologically confirmed diagnosis of 1 of the following:

- Glioblastoma multiforme (grade 4 astrocytoma)

- Gliosarcomas

- Other grade 4 astrocytoma variants (e.g., giant cell)

- Must be enrolled at least 1 week, but no more than 4 weeks, after prior biopsy or

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- At least 6 months

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Total bilirubin ≤ upper limit of normal (ULN)

- AST no greater than 2.5 times ULN

- Creatinine no greater than 1.5 times ULN

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No inability to take oral medications

- No requirement for IV alimentation

- No active uncontrolled peptic ulcer disease

- No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)

- No congenital abnormality (e.g., Fuch's dystrophy)

- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or

- No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production

- No prior allergy or intolerance to dacarbazine

- No other active malignancy requiring treatment

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior chemotherapy for any brain tumor

- No prior temozolomide

- No prior radiotherapy for any brain tumor

- No other concurrent investigational agents

- More than 21 days since prior major surgery (excluding neurosurgical biopsy or brain
tumor resection)

- No prior surgical procedures affecting absorption

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent warfarin

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

At 52 weeks

Safety Issue:


Principal Investigator

Paul Brown

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Glioblastoma
  • Gliosarcoma



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