Bladder CancerPhase 2NCT00246974
Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
A Phase 2 study testing Gemcitabine, Cisplatin and Gefitinib in people with Bladder Cancer, run by AstraZeneca at 14 sites in Germany.
Trial summary
The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Gemcitabine, Cisplatin and Gefitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 14 sitesGermany
- Study dates
- May 2003to Dec 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
- Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
- Locally advanced or metastatic disease
- At least one measurable lesion as defined by RECIST
- Chemotherapy-naiv
Who cannot join
- Previous chemotherapy or other systemic antitumour therapy
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Research Site
Aachen
Research Site
Augsburg
Research Site
Berlin
Research Site
Dresden
Research Site
Freiburg im Breisgau
Research Site
Halle
Research Site
Hamburg
Research Site
Hanover
Research Site
Kassel
Research Site
Mainz
Research Site
Mannheim
Research Site
Münster
Research Site
Tübingen
Research Site
Ulm
About this study
Official title: An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.
- Conditions
- Bladder Cancer
- Being tested
- Gemcitabine, Cisplatin, Gefitinib
- Keywords
- bladder cancer, Transitionel cell cancer of the urothelium
- 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.
GemcitabineDrug
intravenous
CisplatinDrug
intravenous
GefitinibDrug
Also called Iressa, ZD1839
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cisplatin + Gemcitabin Receives: Drug: Gemcitabine; Drug: Cisplatin |
| 2 | Experimental | Cisplatin + Gemcitabin + Gefitinib Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
Secondary outcomes (6)
1. Response rate
2. Overall survival time
3. Time to treatment failure
4. Disease control rate
5. Duration of response
6. Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startMay 2003
- Primary completionOct 2007
- Study completionDec 2007
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.
- More trials run by AstraZenecaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Iressa Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246974
- Sponsor's protocol ID
- 1839IL/0063
- Other IDs
- D7913L00063
- Status last verified
- Oct 2008
- First submitted
- 31 Oct 2005
- Last updated
- 15 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
- ClinicalTrials.gov ID
- NCT00246974
- Acronym / sponsor ID
- 1839IL/0063
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, Transitionel cell cancer of the urothelium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Nov 2005 (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.
The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Gemcitabine, Drug: CisplatinCisplatin + Gemcitabin |
| 2 | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Drug: GefitinibCisplatin + Gemcitabin + Gefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
- Locally advanced or metastatic disease
- At least one measurable lesion as defined by RECIST
- Chemotherapy-naiv
Key exclusion criteria (2 listed)
- Previous chemotherapy or other systemic antitumour therapy
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
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 |
|---|---|---|
| Gemcitabineintravenous | Drug | 1, 2 |
| Cisplatinintravenous | Drug | 1, 2 |
| GefitinibAlso: Iressa, ZD1839oral | Drug | 2 |
Primary outcome
Time to progression (TTP)
6 secondary outcomes
1. Response rate
2. Overall survival time
3. Time to treatment failure
4. Disease control rate
5. Duration of response
6. Safety and tolerability
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 15 Oct 2008.
Related trials for Bladder Cancer
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 2
Intravesical Gem/Doce in Patients With NMIBC
Urinary Bladder Cancer
Active, not recruitingPhase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Advanced Bladder Urothelial Carcinoma, Advanced Renal Pelvis Urothelial Carcinoma
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.
AstraZeneca Iressa Medical Science Director, MD study director
AstraZeneca
14 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 Gemcitabine, Cisplatin and Gefitinib in people with Bladder Cancer, run by AstraZeneca at 14 sites in Germany.
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 4 inclusion and 2 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 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. 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?
Time to progression (TTP). 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 15 Oct 2008.