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Combination Chemotherapy in Treating Patients With Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00014534
Recruitment Status : Completed
First Posted : June 10, 2003
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Bladder Cancer Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 150,000/mm^3

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • AST ≤ 2 times ULN

Renal:

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to bladder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014534


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Dean Bajorin, MD Memorial Sloan Kettering Cancer Center
More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00014534    
Other Study ID Numbers: CALGB-90104
P30CA008748 ( U.S. NIH Grant/Contract )
CALGB-90104
MSKCC-00138
NCI-G01-1935
CDR0000068554 ( Registry Identifier: NCI Physician Data Query )
First Posted: June 10, 2003    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
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:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors