Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-30 @ 8:49 PM
Study NCT ID:
NCT00098995
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2004-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tirapazamine, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077704', 'term': 'Tirapazamine'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2004-12-08', 'studyFirstSubmitQcDate': '2004-12-08', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of tirapazamine'}, {'measure': 'Safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Failure-free survival'}, {'measure': 'Overall survival'}, {'measure': 'Patterns of failure for the site of first failure (local-regional, distant, or both)'}, {'measure': 'Complete response rate at 12 weeks following study completion'}, {'measure': 'Hypoxia by 18F-azomycinarabinoside (FAZA) PET scan at baseline and 12 wks following completion of radiotherapy correlated w/ obj. tumor response by PET- fludeoxyglucose F 18 (FDG) and local-regional failure'}]}, 'conditionsModule': {'keywords': ['stage IB cervical cancer', 'stage IIA cervical cancer', 'stage IIB cervical cancer', 'stage III cervical cancer', 'stage IVA cervical cancer', 'cervical adenocarcinoma', 'cervical adenosquamous cell carcinoma', 'cervical squamous cell carcinoma'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as tirapazamine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tirapazamine may help cisplatin kill more tumor cells by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Tirapazamine may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy in different ways together with combination chemotherapy may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of tirapazamine when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose and the recommended phase II and III dose of tirapazamine when combined with cisplatin and radiotherapy in patients with Stage IB-IVA squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\n* Determine the safety and tolerability of this regimen in these patients.\n\nSecondary\n\n* Determine failure-free survival of patients treated with this regimen.\n* Determine overall survival of patients treated with this regimen.\n* Determine time to locoregional failure in patients treated with this regimen.\n* Determine patterns of failure for the site of first failure in patients treated with this regimen.\n* Determine the 12-week post-treatment complete response rate in patients treated with this regimen.\n\nOUTLINE: This is a multicenter, dose-escalation study of tirapazamine.\n\nPatients receive tirapazamine IV over 2 hours on day 1 of weeks 1-5 and on days 3 and 5 of weeks 1 and 2 (cohort 2 only), OR days 3 and 5 of weeks 1-4 (cohort 3 only). Patients also receive cisplatin IV over 1 hour on day 1 of weeks 1-6. Patients concurrently undergo external beam radiotherapy once daily on days 1-5 for 5-5.5 weeks. After completion of chemoradiotherapy, patients undergo low-dose brachytherapy (up to 2 implants within an 8-week period) OR high-dose brachytherapy twice weekly for 5 treatments. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.\n\nPatients are followed at 2, 4, and 8 weeks, at 3 and 6 months, every 3 months for 2 years, and then every 6 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 3-22 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix\n\n * Stage IB, IIA, IIB, III, or IVA disease\n* No evidence of involvement of para-aortic nodes by CT scan, MRI, fluorodeoxyglucose positron emission tomography, or lymphadenectomy\n\n * Involvement of common iliac nodes allowed\n* No evidence of distant metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Any age\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 6 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin \\< 1.25 times upper limit of normal (ULN)\n* AST and ALT ≤ 3 times ULN\n\nRenal\n\n* Calculated creatinine clearance ≥ 60 mL/min OR\n* Glomerular filtration rate ≥ 60 mL/min\n\nCardiovascular\n\n* No significant cardiac disease that would preclude IV fluid load required for administration of cisplatin\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther\n\n* No symptomatic peripheral neuropathy ≥ grade 2\n* No clinically significant sensori-neural hearing impairment interfering with activities of daily living or requiring a hearing aid\n\n * Audiometric changes alone of any severity allowed\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to tirapazamine or cisplatin\n* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n* No other concurrent uncontrolled illness\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent epoetin alfa\n* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)\n* No concurrent pegfilgrastim\n\nChemotherapy\n\n* No prior chemotherapy for another malignancy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior pelvic or abdominal radiotherapy for another malignancy\n* No prior radiotherapy to ≥ 15% of bone marrow-bearing areas\n* No concurrent intensity-modulated radiotherapy\n* No concurrent interstitial brachytherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior treatment for invasive cervical cancer\n* No other concurrent therapeutic investigational agents\n* No other concurrent anticancer therapy\n* No concurrent systemic retinoids\n* No concurrent amifostine\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00098995', 'briefTitle': 'Tirapazamine, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study Of Tirapazamine In Combination With Radiation And Weekly Cisplatin In Patients With Locally Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': 'PMCC-2004/354'}, 'secondaryIdInfos': [{'id': 'CDR0000393978', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-5485'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'tirapazamine', 'type': 'DRUG'}, {'name': 'brachytherapy', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8006', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Danny Rischin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peter MacCallum Cancer Centre, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter MacCallum Cancer Centre, Australia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}