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
II
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

Publication Information Expand/Collapse

2019

From the other side:The patient perspective on cancer clinical trials [Review]

R Bangs;A Crispino Urologic Oncology: Seminars and Original Investigations May;37(5):331-335; Feb 7 [Epub ahead of print]

PMid: PMID29428573

SWOG S1314: A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer

T Flaig;C Tangen;S Daneshmand;A Alva;MS Lucia;D McConkey;D Theodorescu;A Goldkorn;M Milowsky;R Bangs;G MacVicar;BR Bastos;D Gustafson;M Plets;IM Thompson J Clin Oncol 37(suppl; abstr 4506); ASCO Annual Meeting (May 31-June 4, 2019, Chicago, IL), oral

2016

Summary and recommendations from the National Cancer Institute's Clinical Trials planning meeting on novel therapeutics for non-muscle invasive bladder cancer

SP Lerner;DF Bajorin;CP Dinney;JA Efstathiou;S Groshen;NM Hahn;D Hansel;D Kwiatkowski;M O'Donnell;J Rosenberg;R Svatek;JS Abrams;H Al-Ahmadie;AB Apolo;J Bellmunt;M Callahan;EK Cha;C Drake;J Jarow;A Kamat;W Kim;M Knowles;B Mann;L Marchionni;D McConkey;L McShane;N Ramirez;A Sharabi;AH Sharpe;D Solit;CM Tangen;AT Amiri;E Van Allen;PJ West;JA Witjes;D Quale Bladder Cancer Apr 27;2(2):165-202

PMid: PMID27376138 | PMC number: PMC4927845

2014

Novel neoadjuvant therapy paradigms for bladder cancer: results from the National Cancer Center Institute Forum

C Dinney;D Hansel;D McConkey;W Shipley;M Hagan;R Dreicer;S Lerner;B Czerniak;F Waldman;S Groshen;LD True;E Petricoin;D Theodorescu;A Hruszkewycz;D Bajorin Urologic Oncology 32(8):1108-15;

PMid: PMID25443274 | PMC number: PMC4262150

Other Clinical Trials

SWOG Clinical Trial Number
S1806

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.

Research Committee(s)
Genitourinary Cancer
Activated
04/19/2019
Accrual
4%
Open
Phase
III
SWOG Clinical Trial Number
S1802
SWOG Clinical Trial Number
CTSU/EA8153