A Phase 2 interventional study of nab-paclitaxel and Gemcitabine in Urothelial Carcinoma, Bladder Cancer and Transitional Cell Carcinoma, sponsored by SCRI Development Innovations, LLC. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
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).
This open-label, non-randomized phase II trial evaluates the efficacy and toxicity of first-line treatment with a combination of gemcitabine and nab-paclitaxel, followed by maintenance therapy with nab-paclitaxel alone in patients with metastatic or locally advanced unresectable urothelial cancer. Two groups of patients are eligible: (1) patients who are poor candidates for treatment with cisplatin, and (2) patients with visceral metastases who are incurable and unlikely to derive long-term benefit from treatment with cisplatin-based regimens. Eligible patients will receive a minimum of 3 cycles and up to 6 cycles of treatment with the gemcitabine/nab-paclitaxel combination. Patients having an objective response or stable disease will continue maintenance treatment with single-agent nab-paclitaxel until disease progression, intolerable toxicity, or patient decision to discontinue treatment. Up to 55 patients are planned for enrollment.
6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 3 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
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KEY POINTS:
Inclusion Criteria:
Two groups of patients are eligible:
Poor candidates for cisplatin-based chemotherapy based on the presence of ≥ 1 the following:
Note: Enrollment of patients with 2 or more of these criteria should occur only after careful consideration by the treating physician regarding the patient's ability to tolerate combination chemotherapy.
OR
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).
Exclusion Criteria:
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.
Drug: nab-paclitaxel · Drug: Gemcitabine
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.
Also known as: Abraxane
Induction: 1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle for 3 to 6 cycles.
Also known as: Gemzar
6 Month Progression-free Survival (PFS6)
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. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum.
Time frame: up to 26 weeks
Overall Response Rate
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.
Time frame: every 3 cycles (9 weeks) until treatment discontinuation, an expected average of 1 year.
Clinical Benefit Rate
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.
Time frame: every 3 cycles (9 weeks) until treatment discontinuation, an expected average of 1 year.
Overall Survival
Defined as the time from Day 1 of study drug administration to disease progression or death on study.
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.
The Number of Participants With Grade 3/4/5 Adverse Events (AEs) as a Measure of Safety.
The reported incidence of AEs 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.
Time frame: through study completion, an average of 1 year
| Milestone | Nab-paclitaxel+Gemcitabine |
|---|---|
| Started | 3 |
| Completed | 0 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Progressive disease | 1 |
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. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Defined as the time from Day 1 of study drug administration to disease progression or death on study.
No measurements were reported for this outcome.
The reported incidence of AEs 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.
| Participants | Nab-paclitaxel+Gemcitabine |
|---|---|
| The Number of Participants With Grade 3/4/5 Adverse Events (AEs) as a Measure of Safety. | 2 |
Collected over through study completion, an average of 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nab-paclitaxel+Gemcitabine | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| Event | Nab-paclitaxel+Gemcitabine |
|---|---|
| HypotensionVascular disorders | 1/3 |
| Acute kidney injuryRenal and urinary disorders | 1/3 |
| DehydrationMetabolism and nutrition disorders | 1/3 |
| Event | Nab-paclitaxel+Gemcitabine |
|---|---|
| DehydrationMetabolism and nutrition disorders | 3/3 |
| AnaemiaBlood and lymphatic system disorders | 2/3 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/3 |
| FatigueGeneral disorders | 2/3 |
| HyponatraemiaMetabolism and nutrition disorders | 2/3 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/3 |
| Acute kidney injuryRenal and urinary disorders | 1/3 |
| Alanine aminotransferase increasedInvestigations | 1/3 |
| AnxietyPsychiatric disorders | 1/3 |
| Aspartate aminotransferase increasedInvestigations | 1/3 |
| Age, Categorical(Participants) | Nab-paclitaxel+Gemcitabine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Nab-paclitaxel+Gemcitabine |
|---|---|
| Female | 0 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Nab-paclitaxel+Gemcitabine |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nab-paclitaxel+Gemcitabine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Nab-paclitaxel+Gemcitabine |
|---|---|
| United States | 3 |
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SCRI Development Innovations, LLC