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Phase II Study of Acridine Carboxamide in Patients With Advanced Ovarian Cancer
Alternate Title Acridine Carboxamide in Treating Patients With Advanced Ovarian Cancer
Objectives I. Determine the objective response, response rate, and duration of objective response in patients with advanced ovarian cancer treated with acridine carboxamide. II. Determine the toxicity and pharmacokinetics of this regimen in these patients. Entry Criteria Disease Characteristics: Histologically confirmed ovarian cancer Metastatic or inoperable, locally advanced, progressive disease Must have failed treatment within 1 year of first line platinum and taxane-based therapeutic regimen for advanced disease At least 1 bidimensionally measurable target lesion by CT scan No symptomatic brain metastasis Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 14 days since prior major surgery Other: No other concurrent anticancer agents No other concurrent investigational therapy Patient Characteristics: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastasis present) Transaminases no greater than 2 times ULN (5 times ULN if liver metastasis present) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Clinically normal cardiac function No prior ischemic heart disease within the past 6 months Normal 12 lead electrocardiogram Other: No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer No unstable systemic disease No active uncontrolled infection No concurrent psychological, familial, sociological, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception Expected Enrollment A total of 14-25 patients will be accrued for this study. Outline This is a multicenter study. Patients receive acridine carboxamide IV continuously over days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression.Published Results Dittrich C, Dieras V, Kerbrat P, et al.: Phase II study of XR5000 (DACA), an inhibitor of topoisomerase I and II, administered as a 120-h infusion in patients with advanced ovarian cancer. Invest New Drugs 21 (3): 347-52, 2003.[PUBMED Abstract] Trial Lead Organizations European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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