Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 5:11 AM
Study NCT ID:
NCT00026260
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SU5416 in Treating Patients With Persistent or Recurrent 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': 'C116890', 'term': 'Semaxinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '2001-11-09', 'studyFirstSubmitQcDate': '2003-10-20', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent cervical cancer', 'cervical squamous cell carcinoma'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor.\n\nPURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the antitumor cytostatic activity of SU5416, in terms of 6-month progression-free survival and time to progression, in patients with persistent or recurrent cervical squamous cell carcinoma.\n* Determine the nature and degree of toxicity of this drug in these patients.\n* Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive SU5416 IV over 1 hour on days 1 and 4. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 8-23 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed cervical squamous cell carcinoma\n\n * Persistent or recurrent disease with documented progression\n * No nonsquamous cell cervical malignancies, including adenosquamous carcinoma\n* At least 1 measurable lesion\n\n * At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR\n * At least 10 mm by spiral CT scan\n* Failed prior local therapeutic measures\n* Ineligible for higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population)\n* Tumor must be accessible for biopsy using direct- or guided-needle technique\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* GOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Platelet count at least lower limit of normal\n* Absolute neutrophil count at least 1,500/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT no greater than 2.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN OR\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular:\n\n* No uncompensated coronary artery disease on electrocardiogram or physical examination\n* No myocardial infarction within the past 6 months\n* No severe/unstable angina within the past 6 months\n* No severe peripheral vascular disease\n* No deep vein or arterial thrombosis within the past 3 months\n\nPulmonary:\n\n* No pulmonary embolism within the past 3 months\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* Must have central venous access\n* No uncontrolled diabetes mellitus\n* No prior allergic reaction to paclitaxel\n* No active infection requiring antibiotics\n* No peripheral neuropathy greater than grade 1\n* No contraindications to low-dose (1 mg/day) warfarin or low-molecular weight heparin prophylaxis\n* No claustrophobia that would preclude MRI studies\n* No ferromagnetic implants or pacers\n* No other invasive malignancy within the past 5 years except non-melanoma skin cancer\n* No other concurrent circumstances that would preclude study completion\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n\nBiologic therapy:\n\n* No prior antiangiogenesis agents, including SU5416\n* At least 3 weeks since prior biologic or immunologic agents directed at malignancy\n\nChemotherapy:\n\n* No more than 1 prior chemotherapy regimen, including single or combination cytotoxic drug therapy (radiosensitizers do not count as prior regimen)\n* At least 3 weeks since prior chemotherapy directed at malignancy and recovered\n\nEndocrine therapy:\n\n* At least 1 week since prior hormonal therapy directed at malignancy\n* Concurrent hormone replacement therapy allowed\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy directed at malignancy and recovered\n\nSurgery:\n\n* See Disease Characteristics\n* At least 3 weeks since prior surgery for malignancy and recovered\n\nOther:\n\n* No prior cancer therapy that would preclude study'}, 'identificationModule': {'nctId': 'NCT00026260', 'briefTitle': 'SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix', 'orgStudyIdInfo': {'id': 'CDR0000069013'}, 'secondaryIdInfos': [{'id': 'GOG-0227B'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'semaxanib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert A. Burger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}