SWOG clinical trial number

S1314

A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer

100% Accrual

Accrual

100%

Closed

Phase

100% Accrual

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

SWOG Study S1314 Page

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

Publication Information Expand/Collapse

Other Clinical Trials

S2312

SWOG Clinical Trial Number

A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature

Research Committee(s)

Genitourinary Cancer

Activated

09/03/2024

4% Accrual

Accrual

Open

Phase

S2210

SWOG Clinical Trial Number

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

Research Committee(s)

Genitourinary Cancer

Activated

08/14/2023

9% Accrual

Accrual

Open

Phase

S2200

SWOG Clinical Trial Number

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

16% Accrual

Accrual

16%

Open

Phase

A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer

Research committees

Treatment

Other Study Materials

Eligibility Criteria Expand/Collapse

Publication Information Expand/Collapse

2024

2023

2022

2021

2020

2019

2016

2014

Other Clinical Trials

A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature

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

S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2