Bladder CancerPhase 2NCT00635726
Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer
A Phase 2 study testing Methotrexate, Vinblastine and Doxorubicin in people with Bladder Cancer, run by Hellenic Oncology Research Group at 7 sites in Greece.
Trial summary
This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Methotrexate, Vinblastine and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesGreece
- Study dates
- Feb 2008to Feb 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed transitional cell carcinoma of the urinary bladder.
- Metastatic or locally advanced disease.
- No prior chemotherapy.
- Performance status (World Health Organization) 0-2.
- Measurable or evaluable disease.
- Measurable disease is defined as at least 1 unidimensional measurable lesion
Show all 10Show fewer
- ≥20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
- Adequate liver (bilirubin ≤ 1.5 Upper Normal Limit, serum glutamate-pyruvate aminotransferase/serum glutamic pyruvic transaminase ≤ 2 Upper Normal Limit, ALP ≤ 2.5 Upper Normal Limit), renal (creatinine ≤ 1.5 Upper Normal Limit) and bone marrow (absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3) function.
- Life expectancy > 3 months.
- Patients must be able to understand the nature of this study and give written informed consent.
Who cannot join
- History of serious cardiac disease (unstable angina, severe congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias).
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
- Active infection.
- Uncontrolled inflammation.
- Pregnant or lactating women.
- Psychiatric illness or social situation that would preclude study compliance.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Greece7 sites
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli
401 Military Hospital, Medical Oncology Unit
Athens
Air Forces Military Hospital, Dept. of Medical Oncology
Athens
IASO General Hospital of Athens, 1st Dept. of Medical Oncology
Athens
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
Athens
Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
Piraeus
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki
About this study
Official title: Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer.
Read the detailed description
High dose MVAC and Cisplatin/Gemcitabine combination regimens have shown comparable efficacy in the first line treatment of advanced or metastatic bladder cancer, whereas the latter regimen has better tolerability. The efficacy and tolerability of the sequential administration of these two regimens is not known.
- Conditions
- Bladder Cancer
- Being tested
- Methotrexate, Vinblastine, Doxorubicin, Cisplatin, Gemcitabine
- Keywords
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
VinblastineDrug
Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
DoxorubicinDrug
Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
CisplatinDrug
Also called CDDP
Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
CisplatinDrug
Also called CDDP
Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
GemcitabineDrug
Also called Gemzar
Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MVAC -> GEM+CDDP Receives: Drug: Methotrexate; Drug: Vinblastine; Drug: Doxorubicin; Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)
Secondary outcomes (3)
Time to tumor progression
Measured: 1-year
Overall survival
Measured: 1-year
Toxicity profile
Measured: Toxicity assessment on each chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Responsible party
- Sponsor
- Investigators
- Nikos Androulakis, MD, Principal investigator, University Hospital of Crete, Dept. of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635726
- Sponsor's protocol ID
- CT/07.16
- Status last verified
- Oct 2015
- First submitted
- 11 Mar 2008
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
- ClinicalTrials.gov ID
- NCT00635726
- Acronym / sponsor ID
- CT/07.16
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor accrual
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Mar 2008 (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.
This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer.
Detailed description
High dose MVAC and Cisplatin/Gemcitabine combination regimens have shown comparable efficacy in the first line treatment of advanced or metastatic bladder cancer, whereas the latter regimen has better tolerability. The efficacy and tolerability of the sequential administration of these two regimens is not known.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methotrexate, Drug: Vinblastine, Drug: Doxorubicin, Drug: Cisplatin, Drug: GemcitabineMVAC -> GEM+CDDP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed transitional cell carcinoma of the urinary bladder.
- Metastatic or locally advanced disease.
- No prior chemotherapy.
- Performance status (World Health Organization) 0-2.
- Measurable or evaluable disease.
Key exclusion criteria (6 listed)
- History of serious cardiac disease (unstable angina, severe congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias).
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
- Active infection.
- Uncontrolled inflammation.
- Pregnant or lactating women.
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 |
|---|---|---|
| MethotrexateMethotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses | Drug | 1 |
| VinblastineVinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses | Drug | 1 |
| DoxorubicinDoxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses | Drug | 1 |
| CisplatinAlso: CDDPCisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses | Drug | 1 |
| CisplatinAlso: CDDPCisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses | Drug | 1 |
| GemcitabineAlso: GemzarGemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses | Drug | 1 |
Primary outcome
Overall response rate
Time frame: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)
3 secondary outcomes
Time to tumor progression
Time frame: 1-year
Overall survival
Time frame: 1-year
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Results and safety
The study was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
Nikos Androulakis, MD principal investigator
University Hospital of Crete, Dept. of Medical Oncology
7 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 Methotrexate, Vinblastine and Doxorubicin in people with Bladder Cancer, run by Hellenic Oncology Research Group at 7 sites in Greece.
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 10 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: stopped early, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Greece. 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 was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
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?
Overall response rate (time frame: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)). 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 8 Oct 2015.