Carcinoma, Transitional CellPhase 2NCT04039867
Evaluation of Oxaliplatin and Gemcitabine in Patients With Metastatic Bladder Cancer
A Phase 2 study testing Oxaliplatin with Gemcitabine in people with Carcinoma, Transitional Cell, run by University of California, Irvine at 1 site in United States.
Trial summary
This phase II trial evaluated the impact of Oxaliplatin and Gemcitabine in patients with recurrent or advanced transitional cell carcinoma of the bladder. The combination of Oxaliplatin and Gemcitabine is considered investigational and this study will help in determining if their activity and toxicity profiles are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Transitional Cell
- What is being tested?
- Oxaliplatin with Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2005to 6 Oct 2011
- 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
- All patients must have histologically or cytologically confirmed diagnosis of transitional cell carcinoma of the bladder.
- Patients must have metastatic or locally recurrent transitional cell carcinoma of the bladder. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
- All sites of disease must be assessed and designated as measurable or non- measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable disease must be assessed within 28 days prior to registration. All non-measurable disease must be assessed within 42 days prior to registration.
- Patients must not have more than one prior chemotherapy regimen for recurrent/metastatic disease. Patients with initial locally advanced but nonmetastatic disease are allowed to have one prior chemotherapy regimen as part of the primary curative therapy. All chemotherapy must be completed 4 weeks prior to registration. Any number of prior biologic therapies (e.g. chimeric antibodies or kinase inhibitors) is permitted as part of the chemotherapy regimen.
- Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression by the criteria outlined in Section 10.1.2V following completion of radiation therapy.
- Patients must not have a surgical procedure for bladder cancer within 4 weeks prior to registration. Patients must have completely recovered from all surgery prior to registration.
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- Patients must have adequate bone marrow reserve as evidenced by ANC > 1,500 μl and platelets > 100,000/ μl obtained within 14 days prior to registration.
- Patients must have adequate hepatic function as evidenced by serum bilirubin <1.5x the institutional upper limit of normal. Serum transaminase (SGOT or SGPT) be must < 1.5 x the institutional upper limit of normal serum unless the liver is involved with tumor, in which case serum transaminase (SGOT or SGPT) must be < 5 x the institutional limit of normal. These tests must be obtained within 14 days prior to registration.
- Patients must have a creatinine < 2 x the institutional upper limit of normal obtained within 14 days prior to registration.
- All patients must be 18 years of age or older.
- Patients must have a Zubrod performance of 0-2.
- Patients must not have prior therapy with Oxaliplatin or Gemcitabine.
Who cannot join
- Patients with severe psychiatric disorder are not eligible.
- Patients with known brain metastasis are not eligible. However, brain imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
- Patients with any evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia are not eligible.
- Patients with any evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia are not eligible.
- Patients with severe psychiatric disorder are not eligible.
- Patients with known brain metastasis are not eligible. However, brain imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
About this study
This phase II trial evaluated the impact of Oxaliplatin and Gemcitabine in patients with recurrent or advanced transitional cell carcinoma of the bladder. The combination of Oxaliplatin and Gemcitabine is considered investigational and this study will help in determining if their activity and toxicity profiles are comparable or better than the standard regimens.
Read the detailed description
The combination of Oxaliplatin and Gemcitabine has synergistic effects on a variety of human cancer cell lines in vitro. Clinically, it has demonstrated activity in other malignancies including lung, and pancreas. In the former study, poor prognosis advanced non-small cell lung cancer patients received Gemcitabine 1000mg/m2 and Oxaliplatin 65mg/m2 both on days 1 and 8. The overall response rate was 16%, with no reports of neutropenic fever. In the latter study, locally advanced and metastatic pancreatic cancer patients received Gemcitabine 1000mg/m2 on day 1 and Oxaliplatin 100mg/m2 on day 2 every 2 weeks. The overall response rate was 31%. The toxicity profile included grades 3 to 4 neutropenia and thrombocytopenia in 11%, 14% for nausea or vomiting, 6.2% for diarrhea, and 11% for peripheral neuropathy, with no toxic deaths
There has been one feasibility study evaluating the combination of Oxaliplatin and Gemcitabine in advanced transitional cell carcinoma (TCC) of the urothelium. Twenty patients with advanced urothelial carcinomas who were treated with Gemcitabine and Oxaliplatin at 1500mg/m2 and 85mg/m2 IV respectively, both on day 1 of a 14 day cycle. The median number of cycles was 5 and ranged from 1 to 7. A total of 90 cycles were delivered with 87 assessable for toxicity in 19 patients. No neutropenic fever occurred and G-CSF was not used although allowed as needed. Grades 3 to 4 neutropenia and thrombocytopenia were observed in 9 (10%) and 3 (3%) of the courses given respectively. Grades 1 to 2 neuropathy was noted to be common with only one patient suffering grade 3 neuropathy. Non-hematologic adverse effects were found to be mild. Response rates were not provided.
In summary, there is favorable evidence of antitumor activity in vitro and in clinical studies for a variety of cancers. Furthermore, the toxicity profile of this combination is also favorable. It is therefore logical to evaluate the effectiveness and tolerability of this combination in advanced urothelial carcinoma.
- Conditions
- Carcinoma, Transitional Cell
- Being tested
- Oxaliplatin with Gemcitabine
- Keywords
- Carcinoma, Transitional Cell, Bladder Cancer, oxaliplatin, Gemcitabine
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin with GemcitabineDrug
Also called Gemzar, Eloxatin
Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin with Gemcitabine | Experimental | Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin. Receives: Drug: Oxaliplatin with Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events to Evaluate Tolerability of Oxaliplatin With Gemcitabine
To evaluate the tolerability of administering Oxaliplatin in combination with gemcitabine in patients with recurrent or advanced TCC bladder. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.
Measured: From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year.
Secondary outcomes (2)
Overall Response Rate as Assessed by RECIST Criteria of Patients Who Received Gemcitabine and Oxaliplatin
To assess the overall response rate to the combination of gemcitabine and Oxaliplatin in patients with recurrent or advanced TCC bladder. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Complete Response (CR) is defined as disappearance of all target lestions. Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). ORR = CR + PR
Measured: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Overall Survival of Patients Who Received Gemcitabine and Oxaliplatin
To evaluate overall survival in patients with advanced TCC bladder treated with this combination of gemcitabine and Oxaliplatin.
Measured: From date of registration for 5 years or until death from any cause, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start20 Jan 2005
- Primary completion6 Oct 2011
- Study completion6 Oct 2011
Why it stopped: Trial was terminated due to halt in funding.
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 Carcinoma, Transitional CellStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John P. Fruehauf, University of California, Irvine
- Investigators
- John P Fruehauf, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039867
- Sponsor's protocol ID
- 20043920
- Other IDs
- 20043920, NCI-2011-01249
- Status last verified
- Aug 2023
- First submitted
- 5 Feb 2019
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxaliplatin and Gemcitabine in Patients With Metastatic Bladder Cancer
- ClinicalTrials.gov ID
- NCT04039867
- Acronym / sponsor ID
- 20043920
- Conditions
- Carcinoma, Transitional Cell
- Keywords
- Carcinoma, Transitional Cell, Bladder Cancer, oxaliplatin, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated due to halt in funding.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 20 Jan 2005 (actual)
- Primary completion
- 6 Oct 2011 (actual)
- Study completion
- 6 Oct 2011 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial evaluated the impact of Oxaliplatin and Gemcitabine in patients with recurrent or advanced transitional cell carcinoma of the bladder. The combination of Oxaliplatin and Gemcitabine is considered investigational and this study will help in determining if their activity and toxicity profiles are comparable or better than the standard regimens.
Detailed description
The combination of Oxaliplatin and Gemcitabine has synergistic effects on a variety of human cancer cell lines in vitro. Clinically, it has demonstrated activity in other malignancies including lung, and pancreas. In the former study, poor prognosis advanced non-small cell lung cancer patients received Gemcitabine 1000mg/m2 and Oxaliplatin 65mg/m2 both on days 1 and 8. The overall response rate was 16%, with no reports of neutropenic fever. In the latter study, locally advanced and metastatic pancreatic cancer patients received Gemcitabine 1000mg/m2 on day 1 and Oxaliplatin 100mg/m2 on day 2 every 2 weeks. The overall response rate was 31%. The toxicity profile included grades 3 to 4 neutropenia and thrombocytopenia in 11%, 14% for nausea or vomiting, 6.2% for diarrhea, and 11% for peripheral neuropathy, with no toxic deaths
There has been one feasibility study evaluating the combination of Oxaliplatin and Gemcitabine in advanced transitional cell carcinoma (TCC) of the urothelium. Twenty patients with advanced urothelial carcinomas who were treated with Gemcitabine and Oxaliplatin at 1500mg/m2 and 85mg/m2 IV respectively, both on day 1 of a 14 day cycle. The median number of cycles was 5 and ranged from 1 to 7. A total of 90 cycles were delivered with 87 assessable for toxicity in 19 patients. No neutropenic fever occurred and G-CSF was not used although allowed as needed. Grades 3 to 4 neutropenia and thrombocytopenia were observed in 9 (10%) and 3 (3%) of the courses given respectively. Grades 1 to 2 neuropathy was noted to be common with only one patient suffering grade 3 neuropathy. Non-hematologic adverse effects were found to be mild. Response rates were not provided.
In summary, there is favorable evidence of antitumor activity in vitro and in clinical studies for a variety of cancers. Furthermore, the toxicity profile of this combination is also favorable. It is therefore logical to evaluate the effectiveness and tolerability of this combination in advanced urothelial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin with Gemcitabine | Experimental | Drug: Oxaliplatin with GemcitabineOxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All patients must have histologically or cytologically confirmed diagnosis of transitional cell carcinoma of the bladder.
- Patients must have metastatic or locally recurrent transitional cell carcinoma of the bladder. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
- All sites of disease must be assessed and designated as measurable or non- measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable disease must be assessed within 28 days prior to registration. All non-measurable disease must be assessed within 42 days prior to registration.
- Patients must not have more than one prior chemotherapy regimen for recurrent/metastatic disease. Patients with initial locally advanced but nonmetastatic disease are allowed to have one prior chemotherapy regimen as part of the primary curative therapy. All chemotherapy must be completed 4 weeks prior to registration. Any number of prior biologic therapies (e.g. chimeric antibodies or kinase inhibitors) is permitted as part of the chemotherapy regimen.
- Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression by the criteria outlined in Section 10.1.2V following completion of radiation therapy.
Key exclusion criteria (8 listed)
- Patients with severe psychiatric disorder are not eligible.
- Patients with known brain metastasis are not eligible. However, brain imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
- Patients with any evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia are not eligible.
- Patients with any evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia are not eligible.
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 |
|---|---|---|
| Oxaliplatin with GemcitabineAlso: Gemzar, EloxatinOxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin. | Drug | Oxaliplatin with Gemcitabine |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events to Evaluate Tolerability of Oxaliplatin With Gemcitabine
Time frame: From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year.
To evaluate the tolerability of administering Oxaliplatin in combination with gemcitabine in patients with recurrent or advanced TCC bladder. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.
2 secondary outcomes
Overall Response Rate as Assessed by RECIST Criteria of Patients Who Received Gemcitabine and Oxaliplatin
Time frame: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Overall Survival of Patients Who Received Gemcitabine and Oxaliplatin
Time frame: From date of registration for 5 years or until death from any cause, whichever came first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John P Fruehauf, MD, PhD principal investigator
University of California, Irvine
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 Oxaliplatin with Gemcitabine in people with Carcinoma, Transitional Cell, run by University of California, Irvine 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 8 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: stopped early, as of the sponsor's last update on 21 Aug 2023. 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 2 Jan 2020). 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?
Number of Participants With Treatment-emergent Adverse Events to Evaluate Tolerability of Oxaliplatin With Gemcitabine (time frame: From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year.). 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 21 Aug 2023.