Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173862
First received: June 30, 2005
Last updated: July 23, 2007
Last verified: June 2005
  Purpose

The purpose of this study is to evaluate the efficacy of Gemcitabine plus Ifosfamind as second line chemotherapy in advanced transitional cell carcinoma in terms of response rate and overall survival .


Condition Intervention Phase
Transitional Cell Carcinoma
Drug: Gemcitabine, Ifosfamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2000~2006 ]

Secondary Outcome Measures:
  • Overall Survival, Safety [ Time Frame: 2000~2006 ]

Enrollment: 18
Study Start Date: May 2000
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: A Drug: Gemcitabine, Ifosfamide

Detailed Description:

Cisplatin-based combination chemotherapy produces a response rate of 40-70% in TCC patients. However, only less than 10% of the patients can achieve long-term remission. Until now, there is no standard chemotherapy for cisplatin-failed TCC patients. Both gemcitabine and ifosfamide have been identified to have response rates of 20% or more in pretreated TCC patients. It is thus reasonable to combine these two active drugs as a second-line treatment for TCC.

Patients enrolled must have a pathologically proven urothelial transitional cell carcinoma (TCC) and must have exposed to one cisplatin-based combination chemotherapy for the advanced disease. GI regimen will be continued until maximal response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed transitional cell carcinoma
  • Advanced / metastatic disease failed to prior chemotherapy (diagnostically confirmed disease progression during the treatment of last chemotherapy or within 6 months after the end of last chemotherapy)
  • Presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ³ 20 mm with conventional technique or ³ 10 mm with spiral CT scan
  • Performance status of ECOG 0, 1, 2
  • Age 20 years or older
  • Life expectancy more than 3 months
  • Adequate hematopoietic function as defined below:

    • WBC ³ 3,000/uL
    • Platelets ³ 75,000/Ul
  • Adequate organ function as defined below:

    • Total bilirubin £ 1.5 ´ ULN
    • ALT / AST£ 5 ´ ULN
    • Creatinine £ 1.5 mg/dL
  • Adequate serum electrolyte concentration:

    • 4 mmol/L<[K+] <5.3 mmol/L
    • 0.74 mmol/L<[Mg2+] <1.03 mmol/
    • 2.02 mmol/L<[Ca2+]<2.60 mmol/L
  • Result of ECG assessment: QTC < 460 msec
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Received chemotherapy, radiotherapy, surgery, or other investigational drug within 4weeks prior to entering the study
  • Receiving other concurrent palliative chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
  • Presence of CNS metastasis
  • Previous or current malignancy with the exception of curatively treated non- melanoma skin cancer or cervical carcinoma in situ
  • Presence of serious concomitant illness which might be aggravated by study medication:

    1. Uncontrolled infection (active serious infections that are not controlled by antibiotics)
    2. Peripheral neuropathy grade 2 or higher (by NCI common toxicity criteria in sensory or motor neuropathy)
    3. Clinically significant arrhythmia (electrocardiogram QTc greater than 500 msec)
    4. Prior myocardial infarction or serious coronary arterial disease within the last 12 months
  • Mental status is not fit for clinical trial.
  • Women of child-bearing potential (pregnancy or breast feeding)
  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: NCT00173862

Locations
Taiwan
Department of Oncology , National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chih-Hung Hsu, M.D., Ph.D. Department of Oncology , National Taiwan University Hospital
Study Chair: Ann-Lii Cheng, M.D., Ph.D. Department of Oncology, National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00173862     History of Changes
Other Study ID Numbers: 155I1
Study First Received: June 30, 2005
Last Updated: July 23, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Combination, Chemotherapy,transitional cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Isophosphamide mustard
Ifosfamide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 18, 2014