Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI SWOG-S0121 S0121, NCT00055835

Objectives

1. 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.
2. Determine the feasibility of administering this regimen to these patients.
3. Determine the progression-free survival of patients treated with this regimen.
4. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
5. Determine the response rate (confirmed and unconfirmed) of patients treated with the neoadjuvant regimen and those treated with the whole regimen.
6. Determine the proportion of patients who qualify for concurrent cisplatin and radiotherapy after receiving the neoadjuvant regimen.
7. 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.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• 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

Radiotherapy

• See Disease Characteristics
• No prior pelvic radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least lower limit of normal

Hepatic

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

Renal

• Creatinine clearance at least 60 mL/min

  OR

• Creatinine no greater than ULN

Gastrointestinal

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

Other

• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ulka Vaishampayan, MD, Protocol chair		Ph: 313-576-8715; 800-527-6266 Email: vaishamu@karmanos.org

Registry Information
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
Trial Start Date		2002-11-15
Registered in ClinicalTrials.gov		NCT00055835
Date Submitted to PDQ		2003-01-17
Information Last Verified		2005-04-19
NCI Grant/Contract Number		CA32102

Back to Top