Clinical trial · Interventional
Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)
NCT00014170CI-TRIAL-00011375completedPhase 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)
Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gefitinib)
- description
- Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: gefitinib
- Other: pharmacological study
- Other: laboratory biomarker analysis
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Survival
- timeFrame
- 52 weeks
- description
- The proportion of 'successes' will be estimated using the binomial point estimator (number of 'successes' divided by the total number of evaluable patients) and standard binomial 90% confidence interval estimates. In the unlikely event that accrual has not been completed before the interim analyses are performed, the Duffy-Santner lgorithm will be used to calculate 90% confidence intervals.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed newly diagnosed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma * No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma * Completed standard external beam radiotherapy within the past 2-5 weeks * No evidence of tumor progression during radiotherapy * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 3 times ULN * Creatinine no greater than 1.5 times ULN * No other active malignancy * No uncontrolled infection * No other severe concurrent disease that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor * See Disease Characteristics * No prior stereotactic radiosurgery or interstitial brachytherapy * No more than 15 weeks since prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.