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

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
SWOG-7303
SWOG Clinical Trial Number
SWOG-8221 (INT-0007)

Treatment of Advanced Bladder Cancer with Preoperative Irradiation and Radical Cystectomy versus Radical Cystectomy Alone

Research Committee(s)
Genitourinary Cancer
Activated
10/29/1982
Closed
11/15/1989
Accrual
81%
Closed
Published
SWOG Clinical Trial Number
SWOG-8216/38

Comparison of BCG Immunotherapy and Adriamycin for Superficial Bladder Cancer

Research Committee(s)
Genitourinary Cancer
Activated
12/01/1982
Closed
01/15/1987
Closed
Phase
III
Published