Urologic NeoplasmsPhase 2NCT00034177
Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium
A Phase 2 study testing S-8184 Paclitaxel Injectable Emulsion and Experimental Arm: TOCOSOL Paclitaxel in people with Urologic Neoplasms, run by Achieve Life Sciences.
Trial summary
Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Neoplasms
- What is being tested?
- S-8184 Paclitaxel Injectable Emulsion and Experimental Arm: TOCOSOL Paclitaxel
- Type of treatment
- Injection or infusion
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histologic diagnosis of transitional cell carcinoma of the urothelium including renal pelvis, ureter, bladder, or urethra
- Locally advanced with lymph node disease(unresectable T3-4, N+, M0); metastatic (T any, N any, MI); or locally recurrent disease following initial definitive therapy
- One and only one prior systemic cytotoxic chemotherapy regimen (note that intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy)
- Failure of first line systemic chemotherapy with a platinum-containing combination regimen consisting of MVAC or cisplatin/gemcitabine with cisplatin dosed at 60 mg/m2 or higher per cycle
- Adult (18 years of age or older) patients
- Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
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- Serum creatinine less than 2.0 mg/dL
- Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
- ECOG performance status of 0 - 2
- Bidimensional measurable disease
- Patients who have signed an IRB / Ethics Committee approved informed consent
- Life expectancy at least 12 weeks
- Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
- Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)
Who cannot join
- Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
- Patients with intracranial metastases
- Females who are pregnant or lactating
- Patients with peripheral neuropathy NCI-CTC grade 2 or greater
- Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
- Patients who have had an investigational agent within 4 weeks of study entry
- Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes
About this study
Official title: Safety And Efficacy Of Weekly Administration Of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment Of Patients With Locally Advanced, Metastatic, Or Recurrent Transitional Cell Carcinoma Of The Urothelium
Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.
Read the detailed description
The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.
- Conditions
- Urologic Neoplasms
- Being tested
- S-8184 Paclitaxel Injectable Emulsion, Experimental Arm: TOCOSOL Paclitaxel
- Keywords
- Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium
- Medical subject headings
- Urologic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-8184 Paclitaxel Injectable EmulsionDrug
Experimental Arm: TOCOSOL PaclitaxelDrug
Doses of 80, 100 and 120mg/m2
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate; time to disease progression; duration of response; survival; toxicities
Measured: After all patients completed treatment
Secondary outcomes (1)
To determine time to disease progression
Measured: After all patients have completed treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2002 (estimated)
- Study startApr 2002
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034177
- Sponsor's protocol ID
- SON-8184-1065
- Status last verified
- Jun 2009
- First submitted
- 23 Apr 2002
- Last updated
- 4 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Of Weekly Administration Of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment Of Patients With Locally Advanced, Metastatic, Or Recurrent Transitional Cell Carcinoma Of The Urothelium
- ClinicalTrials.gov ID
- NCT00034177
- Acronym / sponsor ID
- SON-8184-1065
- Conditions
- Urologic Neoplasms
- Keywords
- Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 25 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.
Detailed description
The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologic diagnosis of transitional cell carcinoma of the urothelium including renal pelvis, ureter, bladder, or urethra
- Locally advanced with lymph node disease(unresectable T3-4, N+, M0); metastatic (T any, N any, MI); or locally recurrent disease following initial definitive therapy
- One and only one prior systemic cytotoxic chemotherapy regimen (note that intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy)
- Failure of first line systemic chemotherapy with a platinum-containing combination regimen consisting of MVAC or cisplatin/gemcitabine with cisplatin dosed at 60 mg/m2 or higher per cycle
- Adult (18 years of age or older) patients
Key exclusion criteria (7 listed)
- Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
- Patients with intracranial metastases
- Females who are pregnant or lactating
- Patients with peripheral neuropathy NCI-CTC grade 2 or greater
- Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
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 |
|---|---|---|
| S-8184 Paclitaxel Injectable Emulsion | Drug | – |
| Experimental Arm: TOCOSOL PaclitaxelDoses of 80, 100 and 120mg/m2 | Drug | – |
Primary outcome
Objective response rate; time to disease progression; duration of response; survival; toxicities
Time frame: After all patients completed treatment
1 secondary outcome
To determine time to disease progression
Time frame: After all patients have completed treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-8184 Paclitaxel Injectable Emulsion and Experimental Arm: TOCOSOL Paclitaxel in people with Urologic Neoplasms, run by Achieve Life Sciences.
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 14 inclusion and 7 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 4 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate; time to disease progression; duration of response; survival; toxicities (time frame: After all patients completed treatment). 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 4 Jun 2009.