TerminatedPhase 2

Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma

Stopped: Enrollment issues

United States3 participantsStarted 2017-01-12

Plain-language summary

The purpose of this trial is to determine the benefit of the combination of nab-paclitaxel plus gemcitabine given for 6 cycles, followed by maintenance nab-paclitaxel alone, in patients with cisplatin-ineligible or cisplatin-incurable advanced urothelial carcinoma (UC).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed diagnosis of urothelial carcinoma (UC) that is either metastatic (any N+ M1) or locally advanced and unresectable (T4bN0). A component of urothelial (transitional cell) carcinoma is required.
. Two groups of patients are eligible:
. Poor candidates for cisplatin-based chemotherapy based on the presence of ≥ 1 the following:
. Poor prognosis and defined as cisplatin-incurable due to the presence of metastasis to at least one visceral site (these patients are not required to have any of the cisplatin-ineligibility criteria).
. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
. Patients with brain metastases are allowed if treatment was completed at least 4 weeks prior to study treatment, neurologic symptoms are minimal and stable during the preceding 4 weeks, and maintenance dexamethasone is not required.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

6 Month Progression-free Survival (PFS6)

Timeframe: up to 26 weeks

Trial details

NCT IDNCT02887248

SponsorSCRI Development Innovations, LLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-01

Results submitted2021-11-16

View on ClinicalTrials.gov More Urothelial Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed diagnosis of urothelial carcinoma (UC) that is either metastatic (any N+ M1) or locally advanced and unresectable (T4bN0). A component of urothelial (transitional cell) carcinoma is required.
. Two groups of patients are eligible:
. Poor candidates for cisplatin-based chemotherapy based on the presence of ≥ 1 the following:
. Poor prognosis and defined as cisplatin-incurable due to the presence of metastasis to at least one visceral site (these patients are not required to have any of the cisplatin-ineligibility criteria).
. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
. Patients with brain metastases are allowed if treatment was completed at least 4 weeks prior to study treatment, neurologic symptoms are minimal and stable during the preceding 4 weeks, and maintenance dexamethasone is not required.

Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria