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

NCT ID: NCT00173862

Last Updated: 2007-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31
• Study Completion Date: 2006-06-30

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.

Conditions

Transitional Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Gemcitabine, Ifosfamide

Intervention Type: DRUG

Interventions

Gemcitabine, Ifosfamide

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology , National Taiwan University Hospital

Ann-Lii Cheng, M.D., Ph.D.

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Locations

Department of Oncology , National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

155I1

Identifier Type: -

Identifier Source: org_study_id