Trial Outcomes & Findings for Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer (NCT NCT02560038)

Last Updated: 2018-11-28

Results Overview

Objective Response Rate (ORR) is defined as the proportion of patients achieving either a complete response or a partial response based on imaging at any time during the study. Complete response or partial response is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Results posted on

2018-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	Combination Chemotherapy Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle. Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days). Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days). Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Chemotherapy n=3 Participants Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle. Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days). Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days). Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants
ECOG Performance Status ECOG score of 0	2 Participants n=5 Participants
ECOG Performance Status ECOG score of 1	1 Participants n=5 Participants
ECOG Performance Status ECOG score of 2	0 Participants n=5 Participants
ECOG Performance Status ECOG score of 3	0 Participants n=5 Participants
ECOG Performance Status ECOG score of 4	0 Participants n=5 Participants
ECOG Performance Status ECOG score of 5	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Outcome measures

Outcome measures
Measure	Combination Chemotherapy n=3 Participants Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle. Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days). Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days). Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
Efficacy as Measured by the Objective Response Rate (ORR).	3 Participants

SECONDARY outcome

Timeframe: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Toxicity assessment will be observational. Numbers and types of events will be quantified and graded according to CTCAE.

Outcome measures

Outcome measures
Measure	Combination Chemotherapy n=3 Participants Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle. Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days). Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days). Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
Safety of Drug Regimen as Measured by Number of Adverse Events	124 adverse event

SECONDARY outcome

Timeframe: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Progression is defined using RECIST 1.1 criteria: " At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."

Outcome measures

Outcome measures
Measure	Combination Chemotherapy n=3 Participants Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle. Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days). Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days). Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
Efficacy as Measured by Number Who Progressed	1 Participants

Adverse Events

Combination Chemotherapy

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Chemotherapy n=3 participants at risk Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle. Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days). Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days). Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
Blood and lymphatic system disorders Febrile Neutropenia	66.7% 2/3 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
General disorders Fever	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
General disorders Chills	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Vomitting	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Infections and infestations Urinary Tract Infection	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations White Blood Cell Count Decreased	66.7% 2/3 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Renal and urinary disorders Acute Kidney Injury	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Reproductive system and breast disorders Perineal Pain	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Reproductive system and breast disorders Vaginal Discharge	100.0% 1/1 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Reproductive system and breast disorders Vaginal Pain	100.0% 1/1 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Respiratory, thoracic and mediastinal disorders Aspiration	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Other adverse events

Other adverse events
Measure	Combination Chemotherapy n=3 participants at risk Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle. Gemcitabine: 1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days). Paclitaxel: 175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days). Cisplatin: 70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 5 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Blood and lymphatic system disorders Blood and lymphatic system disorders, Thrombocytopenia	66.7% 2/3 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Cardiac disorders Cardiac disorders, Swelling in center of chest around sternum	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
General disorders General disorders and administration site conditions, Pretibial edema	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
General disorders Fatigue	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
General disorders Pain	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Bloating	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Ileus	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Mucositis oral	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 7 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Rectal Fistula	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Gastrointestinal disorders, Thrush	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Infections and infestations Tooth infection	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Vomitting	33.3% 1/3 • Number of events 4 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Injury, poisoning and procedural complications Injury, poisoning and procedural complications, Bruise on hip	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations Alanine aminotransferase increased	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations Alkaline Phosphate increased	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations Investigations, Elevated BUN	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations Creatinine increased	66.7% 2/3 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations Platelet count decreased	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Investigations Weight gain	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hypokalemia	66.7% 2/3 • Number of events 4 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 4 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hypernatremia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hypocalcemia	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hypomagnesemia	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Metabolism and nutrition disorders Hypophosphatemia	66.7% 2/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 3 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder, Achiness	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Nervous system disorders Paresthesia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Nervous system disorders Peripheral motor neuropathy	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Nervous system disorders Facial muscle weakness	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Nervous system disorders Vasovagal Reaction	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Renal and urinary disorders Urinary incontinence	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Renal and urinary disorders Urinary retention	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Renal and urinary disorders Hematuria	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Renal and urinary disorders Renal and urinary disorders, Acute renal injury	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Vascular disorders Hypotension	33.3% 1/3 • Number of events 2 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Blood and lymphatic system disorders Blood and lymphatic system disorders, Nose Bleed	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Cardiac disorders Cardiac disorders, Angio edema	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Gastrointestinal disorders Gastrointestinal disorders, Swollen tongue	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months
Renal and urinary disorders Renal and urinary disorders, Little urine output	33.3% 1/3 • Number of events 1 • From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Additional Information

Marka Lyons, Research Manager

The University of Texas Health Science Center at Houston

Phone: 713-500-6919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place