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Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder

Phase 3
18 Years
Not Enrolling
Bladder Cancer

Thank you

Trial Information

Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder



- Compare the survival of patients with completely resected locally advanced transitional
cell carcinoma of the bladder treated with adjuvant doxorubicin and gemcitabine
followed by paclitaxel and cisplatin vs adjuvant cisplatin and gemcitabine.


- Compare the toxicity profiles of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to primary tumor
status (5), and number
of dissected nodes (0-10 or unknown vs > 10). Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive adjuvant gemcitabine IV over 30 minutes on days 1, 8, and 15
and cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 4 weeks for up to
4 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive adjuvant doxorubicin IV over 45 minutes followed by
gemcitabine IV over 2 hours on day 1. Patients also receive filgrastim (G-CSF)
subcutaneously (SC) daily on days 3-10. Treatment repeats every 14 days for up to 4
courses in the absence of disease progression or unacceptable toxicity. Beginning 14
days after the completion of doxorubicin and gemcitabine, patients receive paclitaxel
IV over 3 hours and cisplatin IV over 20-30 minutes on day 1. Patients also receive
G-CSF SC daily on days 3-10 or 4-11. Treatment repeats every 14 days for up to 4
courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 18 months, every 6 months for 18 months, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 6 years.

Inclusion Criteria


- Histologically confirmed transitional cell carcinoma of the bladder

- Any T, N+, M0 OR

- T3a-4a, N0, M0

- At least 6 weeks but no more than 3 months since prior complete resection of bladder

- Cystoprostatectomy plus pelvic lymph node dissection in males

- Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus
pelvic lymph node dissection in females

- Negative surgical margins

- Carcinoma in situ allowed

- No partial cystectomy or transurethral bladder tumor resection as definitive
loco-regional therapy

- Prostate cancer detected in resected specimen allowed if post-operative PSA is no
more than 0.05 mg/dL

- No metastatic or recurrent disease by post-operative chest x-ray and CT scan of
abdomen and pelvis



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 150,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2 times ULN

- AST ≤ 2 times ULN


- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance ≥ 60 mL/min


- Normal cardiac function by history, physical exam, or chest radiograph

- Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or
echocardiogram, for prior cardiac disease

- No New York Heart Association class III or IV heart disease

- No serious cardiac arrhythmias including first-, second-, and third-degree heart


- Negative pregnancy test

- No uncontrolled infection

- No other active cancer within the past 5 years except non-melanoma skin cancer or
curatively treated carcinoma in situ of the cervix


Biologic therapy:

- Not specified


- No prior systemic chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy to bladder


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Dean F. Bajorin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

April 2009

Related Keywords:

  • Bladder Cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell



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