Trial Outcomes & Findings for Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract (NCT NCT03159143)
NCT ID: NCT03159143
Last Updated: 2017-08-11
Results Overview
Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 4 years
Results posted on
2017-08-11
Participant Flow
Participant milestones
| Measure |
Docetaxel and Oxaliplatin
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract
Baseline characteristics by cohort
| Measure |
Docetaxel and Oxaliplatin
n=22 Participants
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
|
Age, Continuous
|
66.4 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Patients who received between 1 and 6 cycles of oxaliplatin with docetaxel.
Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
Outcome measures
| Measure |
Docetaxel and Oxaliplatin
n=19 Participants
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
|
Response Rate
|
11 percentage of participants
Interval 3.0 to 31.0
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.
Time to progression (TTP) will be calculated as number of months from the date of first treatment to the date of disease progression or the date of death (disease-related causes) or the cut-off date.
Outcome measures
| Measure |
Docetaxel and Oxaliplatin
n=22 Participants
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
|
Time to Progression (TTP)
|
3 months
Interval 0.2 to 5.8
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Patients who received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects
Percentage of patients who achieved complete response, partial response and stable disease. DCR will be calculated from the first day of the first cycle to the date of metastatic or primary tumor relapse, or last contact date, or date of death (if death comes before disease progression), or data cut-off.
Outcome measures
| Measure |
Docetaxel and Oxaliplatin
n=22 Participants
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
|
Disease Control Rate (DCR)
|
26.3 percentage of participants
Interval 12.0 to 49.0
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.
The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.
Outcome measures
| Measure |
Docetaxel and Oxaliplatin
n=22 Participants
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
|
Overall Survival
|
7 months
Interval 4.6 to 9.4
|
Adverse Events
Docetaxel and Oxaliplatin
Serious events: 16 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel and Oxaliplatin
n=22 participants at risk
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
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Cardiac disorders
Cardiovascular/Arrhythmia - Other
|
4.5%
1/22
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
9.1%
2/22
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
4.5%
1/22
|
|
Gastrointestinal disorders
Gastric ulcer (requires radiographic or endoscopic documentation)
|
4.5%
1/22
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
4.5%
1/22
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
4.5%
1/22
|
|
Gastrointestinal disorders
Diarrhea patients with a colostomy
|
4.5%
1/22
|
|
General disorders
Dehydration
|
4.5%
1/22
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.5%
1/22
|
|
Gastrointestinal disorders
Gastric ulcer
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22
|
|
Infections and infestations
Infection with ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
4.5%
1/22
|
|
Nervous system disorders
Neurology-Other
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Potassium, serum-low (hypokalemia)
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Sodium, serum-low (hyponatremia)
|
4.5%
1/22
|
Other adverse events
| Measure |
Docetaxel and Oxaliplatin
n=22 participants at risk
Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion.
Docetaxel: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2
|
|---|---|
|
Blood and lymphatic system disorders
Platelets
|
13.6%
3/22
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
27.3%
6/22
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
31.8%
7/22
|
|
Blood and lymphatic system disorders
Hemoglobin
|
54.5%
12/22
|
|
Cardiac disorders
Hypotension
|
9.1%
2/22
|
|
General disorders
Insomnia
|
9.1%
2/22
|
|
General disorders
Weight loss
|
9.1%
2/22
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
18.2%
4/22
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
72.7%
16/22
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
18.2%
4/22
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
13.6%
3/22
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
13.6%
3/22
|
|
Gastrointestinal disorders
Dehydration
|
18.2%
4/22
|
|
Gastrointestinal disorders
Constipation
|
22.7%
5/22
|
|
Gastrointestinal disorders
Anorexia
|
31.8%
7/22
|
|
Gastrointestinal disorders
Diarrhea
|
31.8%
7/22
|
|
Gastrointestinal disorders
Vomiting
|
31.8%
7/22
|
|
Gastrointestinal disorders
Nausea
|
50.0%
11/22
|
|
Blood and lymphatic system disorders
Edema: limb
|
22.7%
5/22
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
9.1%
2/22
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
13.6%
3/22
|
|
Nervous system disorders
Neuropathy: sensory
|
54.5%
12/22
|
|
General disorders
Pain, Bone
|
9.1%
2/22
|
|
General disorders
Pain, Extremity-limb
|
9.1%
2/22
|
|
General disorders
Pain, Joint
|
9.1%
2/22
|
|
General disorders
Pain, Vagina
|
9.1%
2/22
|
|
General disorders
Pain, Back
|
13.6%
3/22
|
|
General disorders
Pain, Muscle
|
13.6%
3/22
|
|
General disorders
Pain, Abdomen NOS
|
18.2%
4/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
18.2%
4/22
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
9.1%
2/22
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
9.1%
2/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place