SWOG clinical trial number
S1314
A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
Closed
Phase
Accrual
100%
Abbreviated Title
Phase II COXEN Trial for Localized Bladder Cancer
Activated
07/09/2014
Closed
12/01/2017
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
Research committees
Genitourinary Cancer
Treatment
Cisplatin
Doxorubicin
Filgrastim
Gemcitabine hydrochloride
Methotrexate
Vinblastine Sulfate
Pegfilgrastim
MVAC
Other Study Materials
Eligibility Criteria Expand/Collapse
Histologically proven urothelial Ca of the bladder (mixed histology ok); Stage cT2-T4aN0M0; no prior systemic chemotherapy or previous systemic anthracyclines (intravesical anthracycline is allowed); abdominal/pelvic CT or MRI scan and chest CT scan (or x-ray) w/in 56 days prior to registration; if alk phos is above IULN or presence of suspicious bone pain (or if other clinical suspicion) then a whole body bone scan w/in 56 days prior to registration; PS = 0 or 1; 18 yrs of age or older; must not have peripheral neuropathy >/= Gr2; must not have NYHA Class III or IV heart failure or a known LVEF < 50%; must not have clinically relevant hearing impairment > Gr2; must not have hypersensitivity to cisplatin, gemcitabine, doxorubicin, vinblastine, methotrexate, or filgrastim/pegfilgrastim; must not have incidence of or uncontrolled medical illness that would limit the patient's ability to participate in the protocol; must not be pregnant or nursing; pts of reproductive potential must agree to use an effective contraceptive method during and for 6 months after completing protocol txt (a neg pregnancy test is required w/in 7 days prior to registration); no other prior malignancy is allowed expect for the following: adequately treated basal cell or squamous cell skin Ca, in situ cervical Ca, adequately treated Stage I or II Ca from which the patient is currently in complete remission, or any other Ca from which the patient has been disease free for 5 years. Pts with localized prostate Ca who are being followed by an active surveillance program are also eligible; pts must have tumor tissue from transurethral resection of the bladder tumor (TURBT) available for submission for COXEN testing and must agree to submit 22 FFPE slides; pt must consent (if residual tumor is present) to the submission of FFPE slides; pt must agree to submit voided urine and whole blood; pts must agree to participate in the translational medicine studies outlined in Section 18.3 of the protocol; pts must be offered participation in the ultra pure Circulating Tumor Cells (upCTCs) study.
Adequate renal, hepatic, and hematologic function w/in 28 days prior to registration:
CrCl >/= 60 mL/min; total bilirubin </= 1.5 IULN (or 2.5 x IULN w/ Gilbert's disese); SGOT(AST)/SGPT(ALT) </= 2 X IULN; ANC >/= 1500/mcL; hemoglobin >/= 9 g/dL; platelets = 100,000/mcL
Adequate renal, hepatic, and hematologic function w/in 28 days prior to registration:
CrCl >/= 60 mL/min; total bilirubin </= 1.5 IULN (or 2.5 x IULN w/ Gilbert's disese); SGOT(AST)/SGPT(ALT) </= 2 X IULN; ANC >/= 1500/mcL; hemoglobin >/= 9 g/dL; platelets = 100,000/mcL
Publication Information Expand/Collapse
2024
PMid: PMID37966367 | PMC number: PMC10824507
2023
PMid: PMID37414705 | PMC number: PMC10659139
2022
2021
PMid: PMID33568346 | PMC number: PMC8219246
2020
2019
2016
PMid: PMID27376138 | PMC number: PMC4927845
2014
PMid: PMID25443274 | PMC number: PMC4262150
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SWOG Clinical Trial Number
S2210
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Research Committee(s)
Genitourinary Cancer
Activated
08/14/2023
Accrual
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Open
Phase
SWOG Clinical Trial Number
S2200
S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2
Research Committee(s)
Genitourinary Cancer
Activated
09/19/2022
Accrual
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Open
Phase
SWOG Clinical Trial Number
CTSU/A031901
Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial
Research Committee(s)
Genitourinary Cancer
Activated
05/01/2021
Open
Phase