Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02887248|
Recruitment Status : Terminated (Enrollment issues)
First Posted : September 2, 2016
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma Bladder Cancer Transitional Cell Carcinoma||Drug: nab-paclitaxel Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Nanoparticle Albumin-bound Paclitaxel Plus Gemcitabine as First-line Therapy for the Treatment of Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma|
|Actual Study Start Date :||January 12, 2017|
|Actual Primary Completion Date :||May 1, 2020|
|Actual Study Completion Date :||May 1, 2020|
Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.
Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
Induction: 125 mg/m² by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle for 3 to 6 cycles to be given with Gemcitabine.
Maintenance: single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
Other Name: Abraxane
Induction: 1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle for 3 to 6 cycles.
Other Name: Gemzar
- 6 month progression-free survival (PFS6) [ Time Frame: up to 26 weeks ]The percentage of treated patients who are progression-free at 6 months after start of treatment, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Overall Response Rate [ Time Frame: every 3 cycles (9 weeks) until treatment discontinuation, an expected average of 1 year. ]The proportion of patients with a confirmed complete or partial response (CR or PR) according to RECIST v1.1. CR = disappearance of all target lesions. PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Clinical Benefit Rate [ Time Frame: every 3 cycles (9 weeks) until treatment discontinuation, an expected average of 1 year. ]Defined as the proportion of patients with CR, PR, or stable disease (SD) according to RECIST v1.1. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum of diameters since start of treatment.
- Overall Survival [ Time Frame: every 9 weeks until disease progression or death on study, an expected average of 1 year. Patients with progressive disease will be followed every 3 months for the first year and every 6 months thereafter up to 5 years. ]Defined as the time from Day 1 of study drug administration to disease progression or death on study.
- The number of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as a measure of safety. [ Time Frame: every 3 weeks until treatment discontinuation plus 30 days, an expected average of 1 year. ]The reported incidence of AEs and SAEs with an onset on or after the initiation of therapy will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887248
|United States, Florida|
|Florida Cancer Specialists - South|
|Fort Myers, Florida, United States, 33916|
|Florida Cancer Specialists-North|
|Saint Petersburg, Florida, United States, 33705|
|Florida Cancer Specialists-East|
|West Palm Beach, Florida, United States, 33401|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Center for Cancer and Blood Disorders|
|Fort Worth, Texas, United States, 76104|
|Study Chair:||John Hainsworth, MD||SCRI Development Innovations, LLC|