Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00061620
Recruitment Status : Completed
First Posted : June 2, 2003
Last Update Posted : July 31, 2012
Chiron Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

May 30, 2003
June 2, 2003
July 31, 2012
September 2001
February 2004   (Final data collection date for primary outcome measure)
Maximum tolerated dose (MTD)
MTD determination made from dose level without a dose-limiting toxicity (DLT)
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Complete list of historical versions of study NCT00061620 on Archive Site
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Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies
Phase I Study of Continuous Infusion Schedule of (E)-2'-Deoxy-2'-(Fluoromethylene) Cytidine (Tezacitabine, FMdC) in Hematologic Malignancies
The goal of this clinical research study is to find the highest dose of Tezacitabine (FMdC) which can be safely given as a continuous infusion by vein to patients with hematologic malignancies. The general safety and effectiveness of this drug will also be studied.
Patients with leukemias that have relapsed from previous therapies have a low cure rate. Hence the need to discover new antileukemic agents. Tezacitabine is a nucleoside analogue with equivalent or even superior activity when compared with ara-C in leukemic cell lines. It has shown significant antitumor activity in vitro and in vivo tumor models. Several phase I studies with various dosing schedules have been conducted in solid tumors where the dose-limiting toxicity (DLT) is mainly myelosuppression, usually a favorable feature for development of leukemia. In a phase I study in hematological malignancies, we used Tezacitabine as a bolus infusion daily x 5. The DLT consisted of grade 3 CNS toxicities and mucositis in 3/6 patients. The study is ongoing and we are currently evaluating a dose level of 7.5 mg/m2 as possible Maximum Tolerated Dose (MTD). However, in view of the fact that tezacitabine is a cell cycle specific agent with a short terminal plasma half-life of 2 to 6 hours, a continuous infusion dosing schedule may enhance the activity and reduce the incidence of adverse effects of tezacitabine.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hematologic Malignancies
Drug: Tezacitabine (FMdC)
7.5 mg/m2 bolus infusion daily x 5
Other Names:
  • FMdC
  • (E)-2'-Deoxy-2'-(Fluoromethylene) Cytidine
Experimental: Tezacitabine
Tezacitabine as a bolus infusion daily x 5
Intervention: Drug: Tezacitabine (FMdC)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2004
February 2004   (Final data collection date for primary outcome measure)
  • Patient with relapsed/refractory acute leukemias (AML, ALL, high-grade myelodysplastic syndromes, CMML in transformation with >/= 10% peripheral blood/bone marrow blasts, CML in blast crisis), or patients with relapsed/refractory CLL and an absolute neutrophil count of >/= 1,000/ml and platelet count of >/= 75,000/ml.
  • Signed informed consent indicating that patients are aware of the investigational nature of this study, and in keeping with the policies of this hospital. The only acceptable consent form is attached at the end of this protocol.
  • Age >/= 15 years.
  • ECOG performance status </= 2.
  • No severe, concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for study entry.
  • Pregnant and/or lactating females are not eligible.
  • Normal organ function (serum bilirubin £ 2 mg/dL, serum creatinine £ 2 mg/dL). Patients with renal or liver dysfunction due to organ leukemic involvement may be eligible after discussion with the principle investigator.
  • Patients must be off of all previous chemotherapy, immunotherapy, or radiotherapy for at least 2 weeks prior to entering this study, and must have recovered from all toxic effects, unless life-threatening increases in tumor burden occur.
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Chiron Corporation
Principal Investigator: Stefan Faderl, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP