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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055835 |
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 | Intervention | Phase |
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Bladder Cancer Urethral Cancer |
Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary or recurrent invasive carcinoma of the urothelium
Must meet at least 1 of the following criteria:
Eligible to receive radiotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000271309, SWOG-S0121 |
Study First Received: | March 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00055835 |
Health Authority: | United States: Federal Government |
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 anterior urethral cancer posterior urethral cancer stage IV bladder cancer transitional cell carcinoma of the bladder |
Cystocele Squamous cell carcinoma Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carboplatin Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma Recurrence Carcinoma |
Epidermoid carcinoma Urethral cancer Cisplatin Urologic Diseases Paclitaxel Urethral Neoplasms Carcinoma, squamous cell Gemcitabine Carcinoma, Squamous Cell Urinary tract neoplasm Bladder neoplasm |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Urethral Diseases Antineoplastic Agents, Phytogenic |