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

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

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 .

Study Overview

• Status: Completed
• Conditions: Transitional Cell Carcinoma
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Department of Oncology , National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: Gemcitabine, Ifosfamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	2000~2006

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival, Safety	2000~2006

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Ann-Lii Cheng, M.D., Ph.D., Department of Oncology, National Taiwan University Hospital; Principal Investigator: Chih-Hung Hsu, M.D., Ph.D., Department of Oncology , National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: June 30, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): July 25, 2007
• Last Update Submitted That Met QC Criteria: July 23, 2007
• Last Verified: June 1, 2005

More Information

Terms related to this study

• Keywords: Combination, Chemotherapy,transitional cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Gemcitabine; Ifosfamide
• Other Study ID Numbers: 155I1