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

NCT03159143 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UPCI 04-055
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Transitional Cell Cancer of the Urothelial Tract

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.

  Up to 4 years

Secondary Outcomes (3)

• Time to Progression (TTP)

  Up to 4 years

• Disease Control Rate (DCR)

  Up to 4 years

• Overall Survival

  Up to 4 years

Study Arms (1)

Docetaxel and Oxaliplatin

EXPERIMENTAL

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.

Drug: Docetaxel; Drug: Oxaliplatin

Interventions

Docetaxel DRUG

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.

Also known as: Taxotere

Docetaxel and Oxaliplatin

Oxaliplatin DRUG

Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m\^2

Docetaxel and Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed transitional cell carcinoma of the Urothelial tract.
• Confirmed metastatic disease.
• Measurable progressive disease is required.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leonard Appleman: lead
• Sanofi-Synthelabo: collaborator

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Interventions

Docetaxel; Oxaliplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Leonard Appleman, MD
• Organization: University of Pittsburgh

applemanlj@upmc.edu

412-648-6538

Study Officials

• Leonard Appleman, MD

  Univesity of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a non-randomized Phase II trial in metastatic transitional cell cancer (TCC) of the urothelial tract.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 18, 2017
• Study Start: December 17, 2004
• Primary Completion: June 2, 2009
• Study Completion: December 2, 2009
• Last Updated: August 11, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)