← Back to Search

Alkylating agents

Filgrastim for Bladder Cancer (COXEN Trial)

Phase 2
Waitlist Available
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven bladder cancer (pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma histologies are excluded).
Stage cT2-T4a N0 M0 disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post registration
Awards & highlights

COXEN Trial Summary

This trial uses a program called COXEN to see if looking at tumor biomarkers can predict how a patient will respond to chemotherapy before surgery.

Eligible Conditions
  • Bladder Cancer

COXEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

COXEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate
+1 more
Secondary outcome measures
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Overall Survival
Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
+1 more

COXEN Trial Design

2Treatment groups
Experimental Treatment
Group I: Gemcitabine & CisplatinExperimental Treatment2 Interventions
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
Group II: Dose Dense MVACExperimental Treatment5 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinblastine
1998
Completed Phase 3
~5260
Doxorubicin
2012
Completed Phase 3
~7940
Filgrastim
2000
Completed Phase 3
~3670
Methotrexate
2013
Completed Phase 4
~3800
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,933 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,574 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,430 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Cancer ResearchJournal
A Randomized Phase II Study of Coexpression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Bladder Cancer (SWOG S1314; NCT02177695)
Flaig, Thomas W., Catherine M. Tangen, Siamak Daneshmand, Ajjai Alva, Seth P. Lerner, M. Scott Lucia, David J. McConkey, et al.. 2021. “A Randomized Phase II Study of Coexpression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Bladder Cancer (SWOG S1314; NCT02177695)”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-20-2409.
clinicaltrials.govStudy
S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
2014. "S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02177695.
~22 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top