Metastatic Transitional Cell Cancer of the Urothelial TractPhase 2NCT03159143
Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract
A Phase 2 study testing Docetaxel and Oxaliplatin in people with Metastatic Transitional Cell Cancer of the Urothelial Tract, run by Leonard Appleman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Transitional Cell Cancer of the Urothelial Tract
- What is being tested?
- Docetaxel and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2004to 2 Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder
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.
Read the 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)
- Being tested
- Docetaxel, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
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.
OxaliplatinDrug
Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Docetaxel; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
Measured: Up to 4 years
Secondary outcomes (3)
Time to Progression (TTP)
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.
Measured: Up to 4 years
Disease Control Rate (DCR)
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.
Measured: Up to 4 years
Overall Survival
The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start17 Dec 2004
- Primary completion2 Jun 2009
- Study completion2 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Transitional Cell Cancer of the Urothelial TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a non-randomized Phase II trial in metastatic transitional cell cancer (TCC) of the urothelial tract.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonard Appleman
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Sponsor-investigator, Leonard Appleman, University of Pittsburgh
- Investigators
- Leonard Appleman, MD, Principal investigator, Univesity of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159143
- Sponsor's protocol ID
- UPCI 04-055
- Status last verified
- Aug 2017
- First submitted
- 8 May 2017
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder
- ClinicalTrials.gov ID
- NCT03159143
- Acronym / sponsor ID
- UPCI 04-055
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Leonard ApplemanUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- 17 Dec 2004 (actual)
- Primary completion
- 2 Jun 2009 (actual)
- Study completion
- 2 Dec 2009 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 11 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomized Phase II trial in metastatic transitional cell cancer (TCC) of the urothelial tract.
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and Oxaliplatin | Experimental | Drug: Docetaxel, Drug: OxaliplatinDocetaxel 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel (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. | Drug | Docetaxel and Oxaliplatin |
| OxaliplatinAlkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m^2 | Drug | Docetaxel and Oxaliplatin |
Primary outcome
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.
3 secondary outcomes
Time to Progression (TTP)
Time frame: Up to 4 years
Disease Control Rate (DCR)
Time frame: Up to 4 years
Overall Survival
Time frame: Up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Appleman, MD principal investigator
Univesity of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Oxaliplatin in people with Metastatic Transitional Cell Cancer of the Urothelial Tract, run by Leonard Appleman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.