Clinical trial · Interventional
S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
NCT02177695CI-TRIAL-00080881COXENcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary focus of this study is to see if looking at tumor biomarkers using a program called coexpression extrapolation or "COXEN" may predict a patient's response to chemotherapy before surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine & Cisplatin
- description
- Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Dose Dense MVAC
- description
- Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
- interventionNames
- Drug: Cisplatin
- Drug: Methotrexate
- Drug: Vinblastine
- Drug: Doxorubicin
- Drug: Filgrastim
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven bladder cancer (pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma histologies are excluded). * Stage cT2-T4a N0 M0 disease. * Documented muscle invasive disease with at least one of the following: disease measuring at least 10 mm on cross-sectional imaging OR the presence of tumor-associated hydronephrosis. * Staging scans with abdominal/pelvic CT or MRI scan and CT scan or x-ray of the chest within 56 days prior to registration. If alkaline phosphatase is above the treating institution's upper limit of normal (ULN), presence of suspicious bone pain, or if other clinical suspicion, a whole body bone scan is required within 56 days prior to registration. * Performance status = 0 or 1 * 18 years of age or older * Must have tumor tissue from transurethral resection of the bladder tumor (TURBT) available for submission that is sufficient for COXEN testing and must agree to submission of 20 (10 micron) slides plus 2 (5 micron) slides from the start and end of the 20 slides for a total of 22 unstained slides. * Must agree to collection of tissue (if residual disease is present), urine, and whole blood. * Must agree to participate in the translational medicine studies outlined in the protocol Exclusion Criteria: * Prior systemic cytotoxic chemotherapy or systemic anthracycline * Peripheral neuropathy \>/= Grade 2 * Class III/IV heart failure or known left ventricular ejection fraction (LVEF) \< 50% * Clinically relevant hearing impairment \> Grade 2 * Renal function, calculated creatinine clearance \< 60 mL/min * Hepatic function, total bilirubin \> 1.5 x institutional upper limit of normal (IULN) (or \> 2.5 x IULN with Gilbert's disease); AST \& ALT \> 2 X IULN * Hematologic function, absolute neutrophil count (ANC) \< 1,500/mcL, hemoglobin \< 9 g/dL, and platelets \< 100,000/mcL * Hypersensitivity to cisplatin, gemcitabine, doxorubicin, vinblastine, methotrexate, or filgrastim/pegfilgrastim * Incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) * Pregnant or nursing females * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. However, patients with localized prostate cancer who are being followed by an active surveillance program are eligible.
References
Publications (3)
- DERIVEDBai Z, Osman M, Brendel M, Tangen CM, Flaig TW, Thompson IM, Plets M, Scott Lucia M, Theodorescu D, Gustafson D, Daneshmand S, Meeks JJ, Choi W, Dinney CPN, Elemento O, Lerner SP, McConkey DJ, Faltas BM, Wang F. Predicting response to neoadjuvant chemotherapy in muscle-invasive bladder cancer via interpretable multimodal deep learning. NPJ Digit Med. 2025 Mar 22;8(1):174. doi: 10.1038/s41746-025-01560-y. PMID 40121304
- DERIVEDFlaig TW, Tangen CM, Daneshmand S, Alva AS, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr, Lerner SP. Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695). Eur Urol. 2023 Sep;84(3):341-347. doi: 10.1016/j.eururo.2023.06.014. Epub 2023 Jul 4. PMID 37414705
- DERIVEDFlaig TW, Tangen CM, Daneshmand S, Alva A, Lerner SP, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr. A Randomized Phase II Study of Coexpression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Bladder Cancer (SWOG S1314; NCT02177695). Clin Cancer Res. 2021 May 1;27(9):2435-2441. doi: 10.1158/1078-0432.CCR-20-2409. Epub 2021 Feb 10. PMID 33568346