Bladder CancerPhase 2NCT00234494
Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer
A Phase 2 study testing Cisplatin, Gemcitabine and Bevacizumab in people with Bladder Cancer, run by Christopher Sweeney, MBBS at 11 sites in United States.
Trial summary
Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. 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?
- Cisplatin, Gemcitabine and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2005to Dec 2008
- 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
- Previously untreated or relapsed locally advanced or metastatic transitional cell carcinoma of the bladder. (Patients with pathology showing ANY component of non-transitional cell histology are not eligible).
- Relapsed patients may have received prior chemotherapy ≥ one year prior to study registration as part of a neoadjuvant or adjuvant regimen and must not have had intervening therapy from the end of that treatment until study entry.
- Measurable disease as per RECIST.
- Prior radiation therapy, immunotherapy, cytokine, biologic or vaccine therapy must be greater than 28 days prior to being registered for protocol therapy,
Who cannot join
- No known central nervous system metastasis. (imaging of brain only required if clinically indicated)
- No prior organ allograft.
- No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- No evidence of bleeding diathesis or coagulopathy.
- No history of serious, non-healing wound, ulcer or bone fracture
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to being registered for protocol therapy.
Show all 10Show fewer
- No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled after approval from the study chair.
- No major surgical procedure, open biopsy, or significant traumatic injury less than 28 days prior to being registered for protocol therapy.
- Patients are not eligible if the need for any major surgical procedure is anticipated during the course of the study.
- Any minor surgical procedures, fine needle aspirations or core biopsies must be greater than 7 days prior to being registered for protocol therapy except procedures to secure a vascular access device which must be greater than 7 days prior to the start of protocol therapy.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Chicago
Chicago, Illinois, 60637
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Arnett Cancer Care
Lafayette, Indiana, 47904
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Siteman Cancer Center
St Louis, Missouri, 63110
AP&S Clinic
Terre Haute, Indiana, 47804
About this study
Official title: A Phase II Trial of Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer: Hoosier Oncology Group GU04-75
Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors.
This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.
Read the detailed description
OUTLINE: This is a multi-center study.
- Cisplatin 70 mg/m2 Day 1
- Gemcitabine 1250 mg/m2 Day 1 and 8
- Bevacizumab 15 mg/kg Day 1
Review toxicity every cycle (every 3 weeks) Review for radiographic response every 2 cycles (every six weeks)
Progressive disease = off protocol therapy
Patients will be treated for up to a maximum of 8 cycles of cisplatin and gemcitabine (24 weeks of therapy). If a patient has not progressed by the end of 24 weeks (completion of cisplatin and gemcitabine), then patient will be treated with bevacizumab at 15 mg/kg every three weeks for a maximum of 12 months of bevacizumab therapy (since study entry).
If at any time patient has undue toxicity or progressive disease, patient will be removed from the study and followed until progression and for survival.
If the patient has Grade 3 or 4 neurotoxicity and/or the creatinine rises above 2.0, then the cisplatin will be discontinued and the patient continued on study and treated with gemcitabine and bevacizumab at the same dose and schedule.
ECOG Performance Status 0 or 1
Hematopoietic:
- White blood cell count > 3000/mm3
- Absolute neutrophil count (ANC) > 1500 mm/3
- Platelet count > 100,000/mm3
- Hemoglobin > 8 g/dL (may be transfused or receive erythropoietin support to maintain or exceed this level).
- INR < 1.5
- No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin
Hepatic:
- Total bilirubin of <1.5 mg/dL
- ALT <5 times upper limit of normal for subjects with documented liver metastases; <2.5 times the upper limit of normal for subjects without evidence of liver metastases.
Renal:
- Serum creatinine of < 1.5 mg/dL.
- Urine protein:creatinine ratio < 1.0 at screening
Cardiovascular:
- No history of myocardial infarction or stroke within the last 6 months
- No uncontrolled hypertension (blood pressure of >160 systolic and/or 110 diastolic mmHg on medication)
- No unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure
- No unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease.
Pulmonary:
- Not specified
- Conditions
- Bladder Cancer
- Being tested
- Cisplatin, Gemcitabine, Bevacizumab
- 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.
CisplatinDrug
Cisplatin 70 mg/m2, day 1
GemcitabineDrug
Gemcitabine 1250 mg/m2, day 1 and 8
BevacizumabDrug
Bevacizumab 15mg/kg, day 1
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | Cisplatin + Gemcitabine + Bevacizumab Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.
Measured: 36 months
Secondary outcomes (3)
Overall Survival Time
To estimate overall survival time in months.
Measured: 36 months
Estimate Response Rates
To estimate rate of partial response (PR), complete response (CR) and overall response (PR plus CR).
Measured: 36 months
Duration of Response for Responding Patients
To estimate duration of response for responding patients.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2008
- Study completionDec 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Sweeney, MBBS
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Eli Lilly and Company, Walther Cancer Institute, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Christopher Sweeney, MBBS, Hoosier Cancer Research Network
- Investigators
- Christopher Sweeney, M.B.B.S., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234494
- Sponsor's protocol ID
- HOG GU04-75
- Status last verified
- Feb 2016
- First submitted
- 5 Oct 2005
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hahn NM, Stadler WM, Zon RT, Waterhouse D, Picus J, Nattam S, Johnson CS, Perkins SM, Waddell MJ, Sweeney CJ; Hoosier Oncology Group. Phase II trial of cisplatin, gemcitabine, and bevacizumab as first-line therapy for metastatic urothelial carcinoma: Hoosier Oncology Group GU 04-75. J Clin Oncol. 2011 Apr 20;29(12):1525-30. doi: 10.1200/JCO.2010.31.6067. Epub 2011 Mar 21.
PubMed 21422406
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer: Hoosier Oncology Group GU04-75
- ClinicalTrials.gov ID
- NCT00234494
- Acronym / sponsor ID
- HOG GU04-75
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Christopher Sweeney, MBBSUniversity, hospital or other
- Collaborators
- Genentech, Inc., Eli Lilly and Company, Walther Cancer Institute, Hoosier Cancer Research Network
- Study start
- Nov 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Oct 2005 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors.
This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.
Detailed description
OUTLINE: This is a multi-center study.
- Cisplatin 70 mg/m2 Day 1
- Gemcitabine 1250 mg/m2 Day 1 and 8
- Bevacizumab 15 mg/kg Day 1
Review toxicity every cycle (every 3 weeks) Review for radiographic response every 2 cycles (every six weeks)
Progressive disease = off protocol therapy
Patients will be treated for up to a maximum of 8 cycles of cisplatin and gemcitabine (24 weeks of therapy). If a patient has not progressed by the end of 24 weeks (completion of cisplatin and gemcitabine), then patient will be treated with bevacizumab at 15 mg/kg every three weeks for a maximum of 12 months of bevacizumab therapy (since study entry).
If at any time patient has undue toxicity or progressive disease, patient will be removed from the study and followed until progression and for survival.
If the patient has Grade 3 or 4 neurotoxicity and/or the creatinine rises above 2.0, then the cisplatin will be discontinued and the patient continued on study and treated with gemcitabine and bevacizumab at the same dose and schedule.
ECOG Performance Status 0 or 1
Hematopoietic:
- White blood cell count > 3000/mm3
- Absolute neutrophil count (ANC) > 1500 mm/3
- Platelet count > 100,000/mm3
- Hemoglobin > 8 g/dL (may be transfused or receive erythropoietin support to maintain or exceed this level).
- INR < 1.5
- No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin
Hepatic:
- Total bilirubin of <1.5 mg/dL
- ALT <5 times upper limit of normal for subjects with documented liver metastases; <2.5 times the upper limit of normal for subjects without evidence of liver metastases.
Renal:
- Serum creatinine of < 1.5 mg/dL.
- Urine protein:creatinine ratio < 1.0 at screening
Cardiovascular:
- No history of myocardial infarction or stroke within the last 6 months
- No uncontrolled hypertension (blood pressure of >160 systolic and/or 110 diastolic mmHg on medication)
- No unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure
- No unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease.
Pulmonary:
- Not specified
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Drug: Cisplatin, Drug: Gemcitabine, Drug: BevacizumabCisplatin + Gemcitabine + Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously untreated or relapsed locally advanced or metastatic transitional cell carcinoma of the bladder. (Patients with pathology showing ANY component of non-transitional cell histology are not eligible).
- Relapsed patients may have received prior chemotherapy ≥ one year prior to study registration as part of a neoadjuvant or adjuvant regimen and must not have had intervening therapy from the end of that treatment until study entry.
- Measurable disease as per RECIST.
- Prior radiation therapy, immunotherapy, cytokine, biologic or vaccine therapy must be greater than 28 days prior to being registered for protocol therapy,
Key exclusion criteria (10 listed)
- No known central nervous system metastasis. (imaging of brain only required if clinically indicated)
- No prior organ allograft.
- No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- No evidence of bleeding diathesis or coagulopathy.
- No history of serious, non-healing wound, ulcer or bone fracture
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 |
|---|---|---|
| CisplatinCisplatin 70 mg/m2, day 1 | Drug | Single Group Assignment |
| GemcitabineGemcitabine 1250 mg/m2, day 1 and 8 | Drug | Single Group Assignment |
| BevacizumabBevacizumab 15mg/kg, day 1 | Drug | Single Group Assignment |
Primary outcome
Progression Free Survival
Time frame: 36 months
- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.
3 secondary outcomes
Overall Survival Time
Time frame: 36 months
Estimate Response Rates
Time frame: 36 months
Duration of Response for Responding Patients
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21422406Hahn NM, Stadler WM, Zon RT, Waterhouse D, Picus J, Nattam S, Johnson CS, Perkins SM, Waddell MJ, Sweeney CJ; Hoosier Oncology Group. Phase II trial of cisplatin, gemcitabine, and bevacizumab as first-line therapy for metastatic urothelial carcinoma: Hoosier Oncology Group GU 04-75. J Clin Oncol. 2011 Apr 20;29(12):1525-30. doi: 10.1200/JCO.2010.31.6067. Epub 2011 Mar 21.
- Hoosier Cancer Research Network HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christopher Sweeney, M.B.B.S. study chair
Hoosier Oncology Group, LLC
11 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 Cisplatin, Gemcitabine and Bevacizumab in people with Bladder Cancer, run by Christopher Sweeney, MBBS at 11 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 4 inclusion and 10 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 14 Mar 2016). 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?
Progression Free Survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234494, which also lists 1 linked publication.
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 14 Mar 2016.