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

NCT00173862 | Completed Phase 2

• 1 other identifier: 155I1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 .

Conditions

Transitional Cell Carcinoma

Keywords

Combination, Chemotherapy,transitional cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Response rate

  2000~2006

Secondary Outcomes (1)

• Overall Survival, Safety

  2000~2006

Study Arms (1)

A

EXPERIMENTAL

Drug: Gemcitabine, Ifosfamide

Interventions

Gemcitabine, Ifosfamide DRUG

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• mmol/L\<\[K+\] \<5.3 mmol/L

You may not qualify if:

• 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:
• Uncontrolled infection (active serious infections that are not controlled by antibiotics)
• Peripheral neuropathy grade 2 or higher (by NCI common toxicity criteria in sensory or motor neuropathy)
• Clinically significant arrhythmia (electrocardiogram QTc greater than 500 msec)
• 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology , National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Gemcitabine; Ifosfamide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines

Study Officials

• Chih-Hung Hsu, M.D., Ph.D.

  Department of Oncology , National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ann-Lii Cheng, M.D., Ph.D.

  Department of Oncology, National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2000
• Study Completion: June 1, 2006
• Last Updated: July 25, 2007

Record last verified: 2005-06

Locations

TW (1)