Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00055835

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

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Bladder Cancer

Urethral Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: carboplatin
    • Description: \*AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
    • Arm Group Labels:
    • Type: DRUG
    • Name: cisplatin
    • Description: 75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days)
    • Arm Group Labels:
    • Type: DRUG
    • Name: gemcitabine hydrochloride
    • Description: 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)
    • Arm Group Labels:
    • Type: DRUG
    • Name: paclitaxel
    • Description: 200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)
    • Arm Group Labels:
    • Type: PROCEDURE
    • Name: neoadjuvant therapy
    • Description: Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)
    • Arm Group Labels:
    • Type: RADIATION
    • Name: radiation therapy
    • Description: 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.
    • Arm Group Labels:
Sponsor
  • SWOG Cancer Research Network