Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Tracking Information
First Submitted Date  ICMJE May 8, 2017
First Posted Date  ICMJE May 18, 2017
Results First Submitted Date  ICMJE July 12, 2017
Results First Posted Date  ICMJE August 11, 2017
Last Update Posted Date August 11, 2017
Actual Study Start Date  ICMJE December 17, 2004
Actual Primary Completion Date June 2, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Response Rate [ Time Frame: Up to 4 years ]
Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
Response Rate [ Time Frame: Up to 4 years ]
Evaluate response rate according to RECIST criteria
Change History Complete list of historical versions of study NCT03159143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Time to Progression (TTP) [ Time Frame: Up to 4 years ]
    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.
  • Disease Control Rate (DCR) [ Time Frame: Up to 4 years ]
    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.
  • Overall Survival [ Time Frame: Up to 4 years ]
    The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
  • Progression Free Survival [ Time Frame: Up to 4 years ]
    The progression-free survival will be calculated from the date of first treatment to the date of disease progression or the date of death or the cut-off date.
  • Disease Free Survival [ Time Frame: Up to 4 years ]
    The disease-free survival 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
  • Overall Survival [ Time Frame: Up to 4 years ]
    The overall survival will be calculated from the date of first treatment until death or the cut-off date.
  • Incidence of Treatment-Emergent Adverse Events of IV docetaxel in combination with IV oxaliplatin [ Time Frame: Up to 4 years ]
    Evaluation of safety and tolerance of docetaxel IV (60mg/m^2) administered in combination with oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion, using NCI-CTC criteria version 3.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract
Official Title  ICMJE A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder
Brief Summary The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.
Detailed Description

This non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.

Treatment was administered on an outpatient basis. No other concurrent therapy for malignant disease was administered. Patients received both docetaxel and oxaliplatin, IV on day 1 of each cycle. Treatment will be repeated every 21 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or treatment delay > 3 weeks.

All patients should receive antiemetics prior to treatment. An oral or IV 5-HT3 receptor antagonist in combination with a benzodiazepene and Decadron was recommended. To mitigate docetaxel associated hypersensitivity reactions, Decadron was administered at a dose of 8mg bid, 1 day prior to, the day of, and the day after administration of docetaxel (total of 3 days)

Day 1 of each cycle:

Docetaxel was administered at a dose of 60mg/m2 IV infusion, followed by oxaliplatin at a dose of 110mg/m2 as a 2 hour IV infusion. Oxaliplatin solution was further diluted in an infusion solution of 250 mL to 500 mL Dextrose 5% in Water (D5W). Oxaliplatin was be capped at a maximum BSA of 2.0

Day 2 of each cycle:

Patients received growth factor support as needed. At the discretion of the investigator, patients were treated with both white and red cell growth factors. Generally, white cell support is recommended if patients experience a febrile neutropenia with the preceeding cycle, or are over the age of 70 yrs, and thought to be at a high risk of febrile neutropenia (74-76)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
This is a non-randomized Phase II trial in metastatic transitional cell cancer (TCC) of the urothelial tract.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Transitional Cell Cancer of the Urothelial Tract
Intervention  ICMJE
  • Drug: 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.
    Other Name: Taxotere
  • Drug: Oxaliplatin
    Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m^2
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Drug: Docetaxel
  • Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
22
Original Actual Enrollment  ICMJE
 (submitted: May 17, 2017)
5
Actual Study Completion Date  ICMJE December 2, 2009
Actual Primary Completion Date June 2, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed transitional cell carcinoma of the Urothelial tract.
  • Confirmed metastatic disease.
  • Measurable progressive disease is required.
  • 18 years of age. Because no dosing or adverse event data are currently available on the use of oxaliplatin in patients < 18 years of age, they are excluded from this study.
  • Life expectancy of greater than 6 months.
  • ECOG Performance status of 0-1.
  • Must have received prior treatment with standard of care chemotherapy No more than 2 prior regimens of cytotoxic chemotherapy.
  • No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment.
  • Patients must have acceptable organ function as defined below:

Hematopoietic: WBC > 2500/mm3 or ANC > 1500/mm3, hemoglobin > 9.0 g/dL, platelet count > 100,000/mm3 Hepatic: Bilirubin < 1.5 mg/dL, SGOT/SGPT < 2 x ULN (< 4 x ULN if liver metastases present) Renal: Creatinine < 1.8 mg/dL

  • Adequate neurologic function defined as no clinically significant peripheral neuropathy, defined as any neuropathy ≤ grade 1.
  • Adequate cardiovascular function defined as no active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months.

Exclusion Criteria:

  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • No prior therapy with oxaliplatin is allowed.
  • No history of allergic reactions attributed to the drugs used in this study or compounds of similar chemical or biologic composition.
  • No history of intolerance or allergy to the antiemetics to be administered in conjunction with the study drugs (i.e., 5 HT3 antagonists).
  • No concurrent other active cancer from another primary site, except squamous cell and basal cell carcinoma of the skin.
  • No other serious concomitant illness will be allowed, including interstitial pneumonia, extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, NYHA Class III or IV, serious cardiac arrhythmia, uncontrolled diabetes mellitus or active infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03159143
Other Study ID Numbers  ICMJE UPCI 04-055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leonard Appleman, University of Pittsburgh
Study Sponsor  ICMJE Leonard Appleman
Collaborators  ICMJE Sanofi-Synthelabo
Investigators  ICMJE
Principal Investigator: Leonard Appleman, MD Univesity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP