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Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract

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ClinicalTrials.gov Identifier: NCT03159143
Recruitment Status : Completed
First Posted : May 18, 2017
Results First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Leonard Appleman, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Transitional Cell Cancer of the Urothelial Tract
Interventions Drug: Docetaxel
Drug: Oxaliplatin
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Docetaxel and Oxaliplatin
Hide Arm/Group Description

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

Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title Docetaxel and Oxaliplatin
Hide Arm/Group Description

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 Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
66.4
(39.9 to 83.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
9
  40.9%
Male
13
  59.1%
1.Primary Outcome
Title Response Rate
Hide Description Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received between 1 and 6 cycles of oxaliplatin with docetaxel.
Arm/Group Title Docetaxel and Oxaliplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11
(3 to 31)
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description 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.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.
Arm/Group Title Docetaxel and Oxaliplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
3
(0.2 to 5.8)
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description 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.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects
Arm/Group Title Docetaxel and Oxaliplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
26.3
(12 to 49)
4.Secondary Outcome
Title Overall Survival
Hide Description The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.
Arm/Group Title Docetaxel and Oxaliplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
7
(4.6 to 9.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel and Oxaliplatin
Hide Arm/Group Description

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

All-Cause Mortality
Docetaxel and Oxaliplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel and Oxaliplatin
Affected / at Risk (%)
Total   16/22 (72.73%) 
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC)   2/22 (9.09%) 
Hemoglobin   1/22 (4.55%) 
Potassium, serum-low (hypokalemia)   1/22 (4.55%) 
Sodium, serum-low (hyponatremia)   1/22 (4.55%) 
Cardiac disorders   
Cardiovascular/Arrhythmia - Other   1/22 (4.55%) 
Cardiac-ischemia/infarction   1/22 (4.55%) 
Gastrointestinal disorders   
Vomiting   2/22 (9.09%) 
Gastric ulcer (requires radiographic or endoscopic documentation)   1/22 (4.55%) 
Ileus (or neuroconstipation)   1/22 (4.55%) 
Gastrointestinal - Other   1/22 (4.55%) 
Diarrhea patients with a colostomy   1/22 (4.55%) 
Diarrhea   3/22 (13.64%) 
Gastric ulcer   1/22 (4.55%) 
General disorders   
Dehydration   1/22 (4.55%) 
Infections and infestations   
Infection with ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)   1/22 (4.55%) 
Nervous system disorders   
Neurology-Other   1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)   1/22 (4.55%) 
Hypoxia   1/22 (4.55%) 
Pneumonitis/pulmonary infiltrates   1/22 (4.55%) 
Pulmonary - Other   1/22 (4.55%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel and Oxaliplatin
Affected / at Risk (%)
Total   22/22 (100.00%) 
Blood and lymphatic system disorders   
Platelets   3/22 (13.64%) 
Leukocytes (total WBC)   6/22 (27.27%) 
Neutrophils/granulocytes (ANC/AGC)   7/22 (31.82%) 
Hemoglobin   12/22 (54.55%) 
Edema: limb   5/22 (22.73%) 
Cardiac disorders   
Hypotension   2/22 (9.09%) 
Gastrointestinal disorders   
Gastrointestinal - Other (Specify, __)   3/22 (13.64%) 
Mucositis/stomatitis (clinical exam), Oral cavity   3/22 (13.64%) 
Dehydration   4/22 (18.18%) 
Constipation   5/22 (22.73%) 
Anorexia   7/22 (31.82%) 
Diarrhea   7/22 (31.82%) 
Vomiting   7/22 (31.82%) 
Nausea   11/22 (50.00%) 
General disorders   
Insomnia   2/22 (9.09%) 
Weight loss   2/22 (9.09%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)   4/22 (18.18%) 
Fatigue (asthenia, lethargy, malaise)   16/22 (72.73%) 
Pain, Bone   2/22 (9.09%) 
Pain, Extremity-limb   2/22 (9.09%) 
Pain, Joint   2/22 (9.09%) 
Pain, Vagina   2/22 (9.09%) 
Pain, Back   3/22 (13.64%) 
Pain, Muscle   3/22 (13.64%) 
Pain, Abdomen NOS   4/22 (18.18%) 
Metabolism and nutrition disorders   
Alkaline phosphatase   2/22 (9.09%) 
Nervous system disorders   
Neurology - Other (Specify, __)   3/22 (13.64%) 
Neuropathy: sensory   12/22 (54.55%) 
Renal and urinary disorders   
Renal/Genitourinary - Other (Specify, __)   2/22 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Cough   3/22 (13.64%) 
Dyspnea (shortness of breath)   4/22 (18.18%) 
Skin and subcutaneous tissue disorders   
Hair loss/alopecia (scalp or body)   3/22 (13.64%) 
Injection site reaction/extravasation changes   3/22 (13.64%) 
Rash/desquamation   4/22 (18.18%) 
Vascular disorders   
Phlebitis (including superficial thrombosis)   2/22 (9.09%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Leonard Appleman, MD
Organization: University of Pittsburgh
Phone: 412-648-6538
Responsible Party: Leonard Appleman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03159143     History of Changes
Other Study ID Numbers: UPCI 04-055
First Submitted: May 8, 2017
First Posted: May 18, 2017
Results First Submitted: July 12, 2017
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017