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

Brief Title

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

Official Title

A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma

Brief Summary

      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 .

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Response rate

Secondary Outcome

 Overall Survival, Safety

Condition

Transitional Cell Carcinoma

Intervention

Gemcitabine, Ifosfamide

Study Arms / Comparison Groups

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

May 2000

Completion Date

June 2006

Eligibility 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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Chih-Hung Hsu, M.D., Ph.D., ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT00173862

Organization ID

155I1

Study Sponsor

National Taiwan University Hospital

Study Sponsor

Chih-Hung Hsu, M.D., Ph.D., Principal Investigator, Department of Oncology , National Taiwan University Hospital

Verification Date

June 2005