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Combination Chemotherapy in Treating Patients With Bladder Cancer

This study has been terminated.
(insufficient accrual)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: April 10, 2001
Last updated: September 27, 2013
Last verified: September 2013

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have advanced bladder cancer.

Condition Intervention Phase
Bladder Cancer
Biological: filgrastim
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: March 2004
Study Completion Date: April 2009
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gemcitabine + cisplatin Drug: cisplatin
60 mg/sq m IV
Drug: gemcitabine hydrochloride
1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm
Active Comparator: Gemcitabine + Doxorubicin + Pegfilgrastim Biological: filgrastim
6 mg sub Q
Drug: doxorubicin hydrochloride
50 mg/ sq m IV
Drug: gemcitabine hydrochloride
1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm

Detailed Description:



  • 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 (<T4 vs T4), number of positive lymph nodes (0 or unknown vs 1-5 vs >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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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 block


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00014534

  Show 285 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Study Chair: Dean F. Bajorin, MD Memorial Sloan Kettering Cancer Center.
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00014534     History of Changes
Other Study ID Numbers: CDR0000068554, P30CA008748, CALGB-90104, MSKCC-00138, NCI-G01-1935
Study First Received: April 10, 2001
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Liposomal doxorubicin
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors processed this record on March 01, 2015