Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 8:32 AM
Study NCT ID:
NCT00039494
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2002-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2002-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'At 52 weeks'}, {'measure': 'Overall survival distribution', 'timeFrame': 'From start of study therapy to death due to any cause, up to 15 years', 'description': 'The overall survival distribution will be estimated using the method of Kaplan-Meier. The success probability, i.e., 12-month survival percentage, will be estimated as the number of evaluable patients still alive at 366 days divided by the total number of evaluable patients followed for at least 366 days.'}], 'secondaryOutcomes': [{'measure': 'Time-to-disease progression', 'timeFrame': 'From start of study therapy to documentation of disease progression, up to 15 years', 'description': 'The time-to-progression distribution will be estimated using the Kaplan-Meier method.'}, {'measure': 'Maximum toxicity grade, assessed by Common Terminology Criteria for Adverse Events (CTCAE)', 'timeFrame': 'Up to 15 years', 'description': 'Frequency tables will be reviewed to determine toxicity patterns.'}]}, 'conditionsModule': {'conditions': ['Adult Giant Cell Glioblastoma', 'Adult Glioblastoma', 'Adult Gliosarcoma']}, 'referencesModule': {'references': [{'pmid': '18955445', 'type': 'DERIVED', 'citation': 'Brown PD, Krishnan S, Sarkaria JN, Wu W, Jaeckle KA, Uhm JH, Geoffroy FJ, Arusell R, Kitange G, Jenkins RB, Kugler JW, Morton RF, Rowland KM Jr, Mischel P, Yong WH, Scheithauer BW, Schiff D, Giannini C, Buckner JC; North Central Cancer Treatment Group Study N0177. Phase I/II trial of erlotinib and temozolomide with radiation therapy in the treatment of newly diagnosed glioblastoma multiforme: North Central Cancer Treatment Group Study N0177. J Clin Oncol. 2008 Dec 1;26(34):5603-9. doi: 10.1200/JCO.2008.18.0612. Epub 2008 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'This pilot phase II trial is studying the side effects and best dose of erlotinib when given with temozolomide and radiation therapy and to see how well they work in treating patients with glioblastoma multiforme or other brain tumors. Radiation therapy uses high-energy x-rays to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and temozolomide with radiation therapy may kill more tumor cells.', 'detailedDescription': 'PILOT STUDY OBJECTIVES:\n\nI. 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.\n\nII. 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.\n\nPHASE II OBJECTIVES:\n\nI. Determine the response rate and time to progression in patients treated with this regimen.\n\nII. Determine the 6-month progression-free survival of patients treated with this regimen.\n\nIII. Determine the toxic effects of this regimen in these patients.\n\nOUTLINE: 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).\n\nPILOT 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.\n\nCohorts 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.\n\nPHASE II: Once the MTD of erlotinib is determined, additional patients are treated with erlotinib at the MTD, temozolomide, and radiotherapy as above.\n\nPatients are followed every 3 months for 5 years and then annually for 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed diagnosis of 1 of the following:\n\n * Glioblastoma multiforme (grade 4 astrocytoma)\n * Gliosarcomas\n * Other grade 4 astrocytoma variants (e.g., giant cell)\n* Must be enrolled at least 1 week, but no more than 4 weeks, after prior biopsy or surgery\n* Performance status - ECOG 0-2\n* Performance status - Karnofsky 60-100%\n* At least 6 months\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin ≥ 9 g/dL\n* Total bilirubin ≤ upper limit of normal (ULN)\n* AST no greater than 2.5 times ULN\n* Creatinine no greater than 1.5 times ULN\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No inability to take oral medications\n* No requirement for IV alimentation\n* No active uncontrolled peptic ulcer disease\n* No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)\n* No congenital abnormality (e.g., Fuch's dystrophy)\n* No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)\n* No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)\n* No prior allergy or intolerance to dacarbazine\n* No other active malignancy requiring treatment\n* No other concurrent uncontrolled illness\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No prior chemotherapy for any brain tumor\n* No prior temozolomide\n* No prior radiotherapy for any brain tumor\n* No other concurrent investigational agents\n* More than 21 days since prior major surgery (excluding neurosurgical biopsy or brain tumor resection)\n* No prior surgical procedures affecting absorption\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No concurrent warfarin"}, 'identificationModule': {'nctId': 'NCT00039494', 'briefTitle': 'Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme', 'orgStudyIdInfo': {'id': 'NCI-2009-00640'}, 'secondaryIdInfos': [{'id': 'N0177'}, {'id': 'CDR0000069388'}, {'id': 'NCCTG-N0177'}, {'id': 'U10CA025224', 'link': 'https://reporter.nih.gov/quickSearch/U10CA025224', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (erlotinib hydrochloride, radiation, temozolomide)', 'description': '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.', 'interventionNames': ['Drug: erlotinib hydrochloride', 'Radiation: 3-dimensional conformal radiation therapy', 'Drug: temozolomide']}], 'interventions': [{'name': 'erlotinib hydrochloride', 'type': 'DRUG', 'otherNames': ['CP-358,774', 'erlotinib', 'OSI-774'], 'description': 'Given orally', 'armGroupLabels': ['Treatment (erlotinib hydrochloride, radiation, temozolomide)']}, {'name': '3-dimensional conformal radiation therapy', 'type': 'RADIATION', 'otherNames': ['3D conformal radiation therapy', '3D-CRT'], 'armGroupLabels': ['Treatment (erlotinib hydrochloride, radiation, temozolomide)']}, {'name': 'temozolomide', 'type': 'DRUG', 'otherNames': ['SCH 52365', 'Temodal', 'Temodar', 'TMZ'], 'description': 'Given orally', 'armGroupLabels': ['Treatment (erlotinib hydrochloride, radiation, temozolomide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Cancer Care LLC', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '60504', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush - Copley Medical Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Saint Joseph Medical Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '61520', 'city': 'Canton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Graham Hospital Association', 'geoPoint': {'lat': 40.55809, 'lon': -90.03512}}, {'zip': '62321', 'city': 'Carthage', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 40.41643, 'lon': -91.13625}}, {'zip': '62401', 'city': 'Effingham', 'state': 'Illinois', 'country': 'United States', 'facility': 'Saint Anthony Memorial Hospital', 'geoPoint': {'lat': 39.12004, 'lon': -88.54338}}, {'zip': '61530', 'city': 'Eureka', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eureka Hospital', 'geoPoint': {'lat': 40.72143, 'lon': -89.27286}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Cottage Hospital', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare Galesburg', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Western Illinois Cancer Treatment Center', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '62644', 'city': 'Havana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mason District Hospital', 'geoPoint': {'lat': 40.30004, 'lon': -90.06095}}, {'zip': '61747', 'city': 'Hopedale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hopedale Medical Complex - 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