S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium
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Purpose
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 |
|---|---|---|
|
Bladder Cancer Urethral Cancer |
Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Enrollment: | 7 |
| Study Start Date: | November 2002 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
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Drug: carboplatin
OBJECTIVES:
- 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.
Eligibility| 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
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- 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
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
Contacts and Locations
Show 92 Study Locations| Study Chair: | Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00055835 History of Changes |
| Other Study ID Numbers: | CDR0000271309, S0121, U10CA032102 |
| Study First Received: | March 6, 2003 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
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:
|
Urinary Bladder Neoplasms Urethral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Gemcitabine Cisplatin Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013