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S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055835
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : January 31, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy before radiation therapy, and combining chemotherapy with radiation therapy, may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by cisplatin and radiation therapy in treating patients who have locally advanced or recurrent carcinoma (cancer) of the urothelium.

Condition or disease Intervention/treatment Phase
Bladder Cancer Urethral Cancer Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the overall survival of patients with locally advanced or recurrent carcinoma of the urothelium treated with neoadjuvant carboplatin, paclitaxel, and gemcitabine followed by concurrent cisplatin and radiotherapy.
  • Determine the feasibility of administering this regimen to these patients.
  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine the response rate (confirmed and unconfirmed) of patients treated with the neoadjuvant regimen and those treated with the whole regimen.
  • Determine the proportion of patients who qualify for concurrent cisplatin and radiotherapy after receiving the neoadjuvant regimen.
  • Determine the potential value of suppressor gene expression analysis (p53 and retinoblastoma gene) and HER2 expression as indicators of prognosis and/or response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.

Within 4-8 weeks after the completion of neoadjuvant chemotherapy, patients receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy 5 days a week for 6 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 4 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy
Study Start Date : November 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Intervention Details:
  • Drug: carboplatin
    *AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
    Other Name: Paraplatin
  • Drug: cisplatin
    75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days)
    Other Name: Platinol; CDDP
  • Drug: gemcitabine hydrochloride
    800 mg/m2, IV, over 30 minutes; given on Days 1 & 8, q 21 days, for a maximum of 3 cycles (1 cycle = 21 days)
    Other Name: Gemzar
  • Drug: paclitaxel
    200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
    Other Name: Taxol
  • Procedure: neoadjuvant therapy
    Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)
  • Radiation: radiation therapy
    Radiation treatments will be delivered once daily. Treatment will be given 5 days per week at a dose of 180 to 200 cGy per day. All fields will be treated everyday.

Information from the National Library of Medicine

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


  • Histologically confirmed primary or recurrent invasive carcinoma of the urothelium

    • Transitional, squamous, or mixed cell subtypes allowed
    • Primary disease site must be the urinary bladder or urethra
    • Disease confined to the true pelvis (T2-T4, N0-N3, M0)
    • Must meet at least 1 of the following criteria:

      • Nodal involvement at or below the level of the bifurcation of the iliac vessels
      • Medically or surgically inoperable
      • Patient refused cystectomy
  • Measurable or nonmeasurable disease
  • Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days
  • No extrapelvic metastases
  • Eligible to receive radiotherapy

    • Planned radiotherapy at a SWOG-approved facility



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least lower limit of normal


  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN


  • Creatinine clearance at least 60 mL/min OR
  • Creatinine no greater than ULN


  • No chronic diarrhea
  • No malabsorption
  • No extensive diverticular disease of the colon
  • No inflammatory bowel disease
  • No other pre-existing gastrointestinal disorders


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active infections requiring antibiotics
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission


Biologic therapy

  • Not specified


  • No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer that is also the initial diagnosis
  • No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed more than 6 months ago
  • No prior carboplatin
  • No prior paclitaxel
  • No prior gemcitabine

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior pelvic radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery

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 identifier (NCT number): NCT00055835

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute

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Responsible Party: Southwest Oncology Group Identifier: NCT00055835    
Other Study ID Numbers: CDR0000271309
S0121 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by Southwest Oncology Group:
recurrent bladder cancer
stage III bladder cancer
squamous cell carcinoma of the bladder
stage II bladder cancer
recurrent urethral cancer
urethral cancer associated with invasive bladder cancer
distal urethral cancer
proximal urethral cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urethral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs