Clinical trial · Interventional

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

Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy

NCT00055835CI-TRIAL-00009204completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92
Urethral Cancer	Malignant Urethral Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
carboplatin	Drug	Carboplatin	ALIAS
cisplatin	Drug	Cisplatin	ALIAS
gemcitabine hydrochloride	Drug	Gemcitabine	ALIAS
neoadjuvant therapy	Procedure	—	UNRESOLVED
paclitaxel	Drug	Paclitaxel	ALIAS
radiation therapy	Radiation	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 2002
Primary completion: Jun 1, 2006
Completion: Jun 1, 2006
First posted: Mar 7, 2003
Last update posted: Jan 31, 2013
Enrollment: 7 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: 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

Data updated 22 days agoSource updated Jan 31, 2013source: clinicaltrials

Locations

Locations by country (92)

Country	Sites	Recruiting
United States	92	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.