Bladder NeoplasmsPhase 2NCT00077688
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
A Phase 2 study testing TOCOSOL Paclitaxel in people with Bladder Neoplasms and Ureteral Neoplasms, run by Achieve Life Sciences at 3 sites in United States.
Trial summary
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable 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
- Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms
- What is being tested?
- TOCOSOL Paclitaxel
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2003to 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 (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra
- Stage IV disease
- One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease
- Adequate hematologic function (ANC >/= 1500 cells/mm3 \& platelet count >/= 100,000/mm3)
- Serum creatinine </= 2.0 mg/dL
- Total bilirubin </= 1.5 mg/dL
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- SGOT \& SGPT </= 3 times upper limit of institutional normal values
- PT (INR) \& PTT within institutional lab normal range
- Karnofsky performance status of 60-100%
- At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria
- Signed IRB/EC approved Informed Consent
- Life expectancy of at least 12 weeks
- 18 years of age or older
- Fully recovered from any previous surgery
- Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females)
- Agree not to take vitamin E supplementation while receiving study medication
- Willing to participate in requested follow-up evaluations
- Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug
Who cannot join
- Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel)
- Peripheral neuropathy NCI-CTC grade 2 or greater
- Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug
- An investigational agent within 4 weeks of first dose of study drug
- Concurrent anticonvulsants known to induce P450 isoenzymes
- Patients who are pregnant or lactating
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- A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC
- Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC
- Brain metastasis
- Active bowel obstruction
- Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Medical Center/Greenbaum Cancer Center
Baltimore, Maryland, 21201
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium
- Being tested
- TOCOSOL Paclitaxel
- Medical subject headings
- Urinary Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOCOSOL PaclitaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Secondary outcomes (4)
Time to treatment failure
Time to progression
Progression free survival
Overall survival at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startNov 2003
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder 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
- 44 participants
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077688
- Sponsor's protocol ID
- SON-8184-1073
- Status last verified
- Jun 2009
- First submitted
- 10 Feb 2004
- 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
- A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium
- ClinicalTrials.gov ID
- NCT00077688
- Acronym / sponsor ID
- SON-8184-1073
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Feb 2004 (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 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium
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 (18 listed)
- Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra
- Stage IV disease
- One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease
- Adequate hematologic function (ANC >/= 1500 cells/mm3 \& platelet count >/= 100,000/mm3)
- Serum creatinine </= 2.0 mg/dL
Key exclusion criteria (11 listed)
- Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel)
- Peripheral neuropathy NCI-CTC grade 2 or greater
- Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug
- An investigational agent within 4 weeks of first dose of study drug
- Concurrent anticonvulsants known to induce P450 isoenzymes
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 |
|---|---|---|
| TOCOSOL Paclitaxel | Drug | – |
Primary outcome
Objective response rate
4 secondary outcomes
Time to treatment failure
Time to progression
Progression free survival
Overall survival at 2 years
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TOCOSOL Paclitaxel in people with Bladder Neoplasms and Ureteral Neoplasms, run by Achieve Life Sciences at 3 sites 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 18 inclusion and 11 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.
Where is the study taking place?
The record lists 3 sites 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?
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. 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.