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6 results on '"Kuzur, Michel E."'

5. Combination chemotherapy with gemcitabine and irinotecan in patients with previously treated carcinoma of an unknown primary siteThe following institutions are Minnie Pearl Cancer Research Network Participating Sites: Tennessee Oncology, PLLC (Nashville, TN); Wellstar Cancer Research (Marietta, GA); Consultants in Blood Disorders & Cancer (Louisville, KY); Graves‐Gilbert Clinic (Bowling Green, KY); Grand Rapids CCOP (Grand Rapids, MI); Upstate Carolina CCOP (Spartanburg, SC); Northeast Georgia Medical Center (Gainesville, GA); King's Daughters' Medical Center (Ashland, KY); Pheobe Cancer Center (Albany, GA); The Reading Hospital and Medical Center (Reading, PA); and Montana Cancer Specialists (Missoula, MT).: A Minnie Pearl Cancer Research Network Phase II trial

Author

Hainsworth, John D., Spigel, David R., Raefsky, Eric L., Kuzur, Michel E., Yost, Kathleen, Kommor, Michael, Litchy, Sharlene, and Greco, F. Anthony

Abstract

The current study was performed to evaluate the activity of combination chemotherapy with gemcitabine and irinotecan in patients with previously treated carcinoma of an unknown primary site.Patients with carcinoma of an unknown primary site who had received one previous chemotherapy regimen were eligible for this study. All patients received gemcitabine at a dose of 1000mg/m2 intravenously (i.v.) and irinotecan at a dose of 100 mg/m2 i.v. on Days 1 and 8; treatment courses were repeated every 21 days. Patients were evaluated for response after completing two courses of treatment; responders/stable patients continued treatment for a recommended six courses.Forty patients entered this multicenter, community‐based Phase II trial between September 2000 and July 2003. Four of these 40 patients (10%) achieved objective responses (a partial response in 3 patients and a complete response in 1 patient). An additional 17 patients (43%) had stable disease/minor response at first reevaluation; 7 of these patients (18%) remained stable for longer than 6 months. The median survival for the entire group was 4.5 months, with 1‐year and 2‐year survival rates of 25% and 13%, respectively. The treatment was well tolerated by most patients. Neutropenia was the most common Grade 3/4 toxicity (according to the National Cancer Institute Common Toxicity Criteria, version 3.0) (occurring in 36% of patients). Myelosuppression‐related complications were uncommon, as were severe nonhematologic toxicities.The combination of gemcitabine and irinotecan has modest activity and is well tolerated in patients with recurrent/refractory carcinoma of an unknown primary site. Treatment‐related toxicity, particularly myelosuppression, appears to be less severe than toxicity produced by the taxane and platinum regimens frequently used in the first‐line therapy of these patients. Evaluation of the gemcitabine and irinotecan combination as first‐line therapy is indicated. Cancer 2005. © 2005 American Cancer Society.

Published
2005
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6. Phase I. Trial of irinotecan plus carboplatin in two dose schedules.

Author

Jones SF, Burris HA 3rd, Hainsworth JD, Yardley DA, Raefsky EA, Miranda FT, Kuzur ME, Willcutt NT, White MB, and Greco FA

Subjects
Adult, Aged, Antineoplastic Agents toxicity, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols toxicity, Camptothecin toxicity, Carboplatin toxicity, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Irinotecan, Male, Maximum Tolerated Dose, Middle Aged, Neoplasms drug therapy, Randomized Controlled Trials as Topic, Treatment Outcome, Antineoplastic Agents administration & dosage, Camptothecin administration & dosage, Camptothecin analogs & derivatives, Carboplatin administration & dosage
Abstract

A phase I study of carboplatin (Paraplatin) administered in two different dosing schedules (single dose every 4 weeks and weekly dosing) in combination with weekly irinotecan (CPT-11, Camptosar) was conducted in patients with relapsed or refractory advanced malignancies. Fifty-three patients with a variety of tumor types were randomly enrolled on the two different treatment regimens and have received a total of 163 cycles of treatment to date. Twenty-six patients received weekly irinotecan in combination with a single fixed dose of every-4-week carboplatin (arm 1). Initially, patients received irinotecan on days 1, 8, and 15, in combination with fixed-dose carboplatin at an area under the concentration-time curve (AUC) of 5.5 (Calvert formula) on day 1 every 28 days. Due to dose-limiting toxicities encountered at the first two dose levels, the protocol was amended to decrease the fixed dose of carboplatin to an AUC of 4.0 every 4 weeks. Dose-limiting toxicity was again encountered, so the day-15 dose of irinotecan was eliminated from the dosing regimen. The recommended phase II dose for heavily pretreated patients is irinotecan at 60 mg/m2 on days 1 and 8 in combination with carboplatin at AUC 4.0 on day 1 with cycles repeated every 28 days. Twenty-seven patients were treated with weekly irinotecan in combination with fixed-dose weekly carboplatin (arm 2). The initial dosing regimen consisted of irinotecan in combination with fixed-dose carboplatin at an AUC of 1.8 on days 1, 8, and 15, with treatment cycles repeated every 28 days. Due to the development of dose-limiting toxicities at the first two dose levels, the dosing regimen was subsequently amended to weekly irinotecan in combination with fixed-dose carboplatin at AUC 2.0 on days 1 and 8 only, and the dosing interval was shortened to every 21 days. With this amended regimen, the recommended phase II doses are irinotecan at 90 mg/m2 in combination with carboplatin at AUC 2.0 on days 1 and 8, with treatment cycles repeated every 21 days.

Published
2003

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