Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00012259
First received: March 3, 2001
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: troxacitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Conventional Response Rate [ Designated as safety issue: No ]
    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).


Secondary Outcome Measures:
  • Percent of Patients Returning to Chronic Phase [ Designated as safety issue: No ]
  • Toxicity Profile [ Designated as safety issue: Yes ]
  • Survival Duration [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: October 2000
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: troxacitabine Drug: troxacitabine
Other Name: 8 mg/m2 administered IV over 30 minutes per day for 5 consecutive days

Detailed Description:

OBJECTIVES: I. Determine the response rate, in terms of achieving complete hematologic remission, partial hematologic remission, hematologic improvement, partial response, or back to chronic phase status, in patients with blastic phase chronic myelogenous leukemia treated with troxacitabine. II. Determine the proportion of patients whose disease returns to chronic phase and remains at that level for at least 3 months when treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the duration of survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive troxacitabine IV over 30 minutes on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks until relapse.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 14 months.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML) with blasts of non-lymphoid origin Blastic phase defined as: At least 30% blasts in the blood or bone marrow OR Presence of extramedullary infiltration outside the liver or spleen No leukemic CNS involvement

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine less than 1.8 mg/dL if creatinine clearance at least 45 mL/min Other: No known hypersensitivity to troxacitabine or its analogues No active uncontrolled serious infection No other severe medical condition that would preclude study No neurologic or psychiatric disorders that would preclude informed consent No uncontrolled underlying medical condition or underlying condition that could be aggrevated by treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 24 hours since prior hydroxyurea Prior STI571 for blastic phase chronic myelogenous leukemia allowed No other prior chemotherapy for blastic phase disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 14 days since prior investigational agents and recovered No other concurrent investigational agents

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012259

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, United States, 90048
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, Florida
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-2410
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Shire
Investigators
Study Chair: Francis J. Giles, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00012259     History of Changes
Other Study ID Numbers: SHIRE-BCH-4556-214, CDR0000068498, NCI-V01-1648
Study First Received: March 3, 2001
Last Updated: May 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Shire:
relapsing chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Troxacitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 23, 2014