Bladder CancerPhase 2NCT00268450
Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery
A Phase 2 study testing bevacizumab, cisplatin and gemcitabine hydrochloride in people with Bladder Cancer, run by Medical University of South Carolina at 4 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- bevacizumab, cisplatin and gemcitabine hydrochloride
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Sep 2005to Apr 2012
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell cancer (TCC) of the bladder
- Staged as follows:
- Muscle invasive (T2-T4a)
- Node negative (N0)
- No histologically or cytologically proven lymph node metastases
- Nonmetastatic (M0)
- No evidence of distant metastases
- Resectable disease
- Able to begin protocol treatment within 6 weeks after transurethral resection and cystoscopic evaluation
- No central nervous system or brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status of 0-2
- Karnofsky 60-100%
- White blood cell count ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- AST(SGOT) and ALT(SGPT) ≤ 2 times upper limit of normal
- Bilirubin ≤1.5 mg/dL
- Creatinine clearance ≥ 60 mL/min
- Urine protein/creatinine ratio < 1.0
- Blood pressure ≤150/100 mm Hg
- No prohibitive medical risks for chemotherapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, gemcitabine hydrochloride, or paclitaxel
- No unstable angina
- No history of myocardial infarction within the past 6 months
- No cardiac arrhythmias
- No New York Heart Association (NYHA) congestive heart failure ≥ grade 2
- No history of stroke within the past 6 months
- No clinically significant peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious nonhealing wound, ulcer, or bone fracture
- No psychiatric illness or other psychosocial situation that would limit ability to comply with study and/or follow-up procedures
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must agree to use adequate contraception prior to study entry and for the duration of study participation
- No significant traumatic injury with in the past 28 days
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy
- No prior pelvic radiation therapy
- More than 4 weeks since prior participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- No concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- No major surgical procedure or open biopsy within the past 28 days
- No anticipation of need for major surgical procedure during the course of the study
- No minor surgical procedures, fine-needle aspirations, or core biopsies within the past 7 days
- No concurrent treatment with hormones or other chemotherapeutic agents except the following:
- Steroids given for adrenal failure
- Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
- Intermittent use of dexamethasone as an antiemetic in solid tumor protocols
- No other concurrent investigational or commercial agents or therapies
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
McLeod Regional Medical Center
Florence, South Carolina, 29501
Lowcountry Hematology and Oncology, PA
Mt. Pleasant, South Carolina, 29464-3233
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder
RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.
- Conditions
- Bladder Cancer
- Being tested
- bevacizumab, cisplatin, gemcitabine hydrochloride, paclitaxel, cysectomy
- Keywords
- transitional cell carcinoma of the bladder, stage III bladder cancer, stage II bladder cancer, recurrent 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.
bevacizumabBiological
Also called avastin
Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles
After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles
cisplatinDrug
Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles
Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles
paclitaxelDrug
After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles
cysectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| study intervention | Experimental | Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin. Receives: Biological: bevacizumab; Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Procedure: cysectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
Measured: From day of first treatment until after cycle 3
Secondary outcomes (6)
Urinary Survivin Levels
Measured: Baseline, week 6 and week 12
Urinary Cytogenitics
Measured: baseline and week 12
Progression Free Survival
Measured: from first treatment until time of progression or death, whichever comes first
Median Overall Surivial
Measured: from first treatment until death
Percentage of Planned Dose Received
Measured: from first treatment until end of week 12
Rate of Post-operative Complications
Measured: from first treatment until up to 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study start21 Sep 2005
- Primary completionApr 2012
- Study completionApr 2012
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 Bladder CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S. Kraft, MD, Study chair, Medical University of South CarolinaGustavo Leone, Study chair, Medical University of South Carolina, Hollings Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268450
- Sponsor's protocol ID
- CDR0000454937
- Other IDs
- MUSC-AVF-3312, MUSC-HR-15537, GENENTECH-AVF-3312, MUSC-CTO-100892
- Status last verified
- May 2018
- First submitted
- 20 Dec 2005
- Last updated
- 12 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder
- ClinicalTrials.gov ID
- NCT00268450
- Acronym / sponsor ID
- CDR0000454937
- Conditions
- Bladder Cancer
- Keywords
- transitional cell carcinoma of the bladder, stage III bladder cancer, stage II bladder cancer, recurrent bladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 21 Sep 2005 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Dec 2005 (estimated)
- Results
- Posted 12 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study intervention | Experimental | Biological: bevacizumab, Drug: cisplatin, Drug: gemcitabine hydrochloride, Drug: paclitaxel, Procedure: cysectomyNeo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bevacizumabAlso: avastinBefore surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles | Biological | study intervention |
| cisplatinBefore surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles | Drug | study intervention |
| gemcitabine hydrochlorideBefore surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles | Drug | study intervention |
| paclitaxelAfter surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles | Drug | study intervention |
| cysectomy | Procedure or surgery | study intervention |
Primary outcome
Complete Remission Rate
Time frame: From day of first treatment until after cycle 3
6 secondary outcomes
Urinary Survivin Levels
Time frame: Baseline, week 6 and week 12
Urinary Cytogenitics
Time frame: baseline and week 12
Progression Free Survival
Time frame: from first treatment until time of progression or death, whichever comes first
Median Overall Surivial
Time frame: from first treatment until death
Percentage of Planned Dose Received
Time frame: from first treatment until end of week 12
Rate of Post-operative Complications
Time frame: from first treatment until up to 48 hours after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bladder Cancer
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
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RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
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Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
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The Vanguard Study: Testing a New Way to Screen for Cancer
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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.
Andrew S. Kraft, MD study chair
Medical University of South Carolina
Gustavo Leone study chair
Medical University of South Carolina, Hollings Cancer Center
4 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 bevacizumab, cisplatin and gemcitabine hydrochloride in people with Bladder Cancer, run by Medical University of South Carolina at 4 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?
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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 12 Jul 2018). 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?
Complete Remission Rate (time frame: From day of first treatment until after cycle 3). 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 12 Jul 2018.