SWOG clinical trial number
S0121

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

Closed
Phase
Accrual
9%
Abbreviated Title
Local Bladder
Activated
11/15/2002
Closed
06/01/2005
Participants
NCORP, Members, UCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists

Research committees

Genitourinary Cancer

Treatment

Cisplatin Paclitaxel Carboplatin Gemcitabine hydrochloride Radiation Therapy Surgery

Eligibility Criteria Expand/Collapse

Pts must have histo (TCC, squamous, mixed) proven primary or recurrent but invasive urothelial ca, which is confined to the true pelvis (T2-4, N0-3, M0) w/one or more of the following: nodal involvement at or below the level of bifurcation of the iliac vessels, medically or surgically inoperable and/or refusing cystectomy. Pts w/extra-pelvic mets are ineligible. Tumor invasion of the muscularis must be documented by cystoscopy w/biopsies w/detailed bladder mapping and extent of tumor removal described w/in 56 days prior to registration. X-rays/scans for tumor mx must be obtained w/in 28 days prior to reg. Pts must have a Zubrod PS of 0-2, creatinine clearance >/= 60 ml/min or serum creatinine of </= IULN, serum bili </= IULN, SGOT or SGPT </= 2.5 X IULN, granulocytes >/= 1,500, PLTS >/= ILLN w/in 28 days of reg. Pts must have recovered from effects of any prior surgery. Pts must have RT consult w/in 28 days prior to reg. There must be plans that RT will be given at a SWOG approved facility. Pts must have had no prior pelvic RT or systemic chemo. If current dx is for recurrent disease, prior adj chemo is permitted if completed more than 6 mos prior to reg and if it did not contain carbo, paclitaxel or gem. Pts must not have any active infections requiring treatment w/antibiotics. Pts must not have pre-existing GI disorders. Pts must be offered participation on correlative studies outlined in Section 15.0.

Other Clinical Trials

SWOG Clinical Trial Number
S2312
SWOG Clinical Trial Number
S2210

S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"

Research Committee(s)
Genitourinary Cancer
Activated
08/14/2023
Accrual
7%
Open
Phase
SWOG Clinical Trial Number
S2200