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| ID | Type | Description | Link |
|---|---|---|---|
| MUSC-AVF-3312 | |||
| MUSC-HR-15537 | |||
| GENENTECH-AVF-3312 | |||
| MUSC-CTO-100892 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate | From day of first treatment until after cycle 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Survivin Levels | Baseline, week 6 and week 12 | |
| Urinary Cytogenitics | baseline and week 12 | |
| Progression Free Survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell cancer (TCC) of the bladder
Staged as follows:
Muscle invasive (T2-T4a)
Node negative (N0)
Nonmetastatic (M0)
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:
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:
No other concurrent investigational or commercial agents or therapies
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| Name | Affiliation | Role |
|---|---|---|
| Andrew S. Kraft, MD | Medical University of South Carolina | Study Chair |
| Gustavo Leone | Medical University of South Carolina, Hollings Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Intervention | 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. bevacizumab: 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 cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles cysectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cisplatin | Drug | Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles |
|
| gemcitabine hydrochloride | Drug | Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles |
|
| paclitaxel | Drug | After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles |
|
| cysectomy | Procedure |
|
| from first treatment until time of progression or death, whichever comes first |
| Median Overall Surivial | from first treatment until death |
| Percentage of Planned Dose Received | from first treatment until end of week 12 |
| Rate of Post-operative Complications | from first treatment until up to 48 hours after surgery. |
| McLeod Regional Medical Center |
| Florence |
| South Carolina |
| 29501 |
| United States |
| Lowcountry Hematology and Oncology, PA | Mt. Pleasant | South Carolina | 29464-3233 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Intervention | 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. bevacizumab: 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 cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles cysectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Remission Rate | Data for this outcome measure was not collected | Posted | From day of first treatment until after cycle 3 |
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| Secondary | Urinary Survivin Levels | Data for this outcome measure was not collected | Posted | Baseline, week 6 and week 12 |
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| Secondary | Urinary Cytogenitics | Data for this outcome measure was not collected | Posted | baseline and week 12 |
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| Secondary | Progression Free Survival | Data for this outcome measure was not collected | Posted | from first treatment until time of progression or death, whichever comes first |
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| Secondary | Median Overall Surivial | Data for this outcome measure was not collected | Posted | from first treatment until death |
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| Secondary | Percentage of Planned Dose Received | Data for this outcome measure was not collected | Posted | from first treatment until end of week 12 |
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| Secondary | Rate of Post-operative Complications | Data for this outcome measure was not collected | Posted | from first treatment until up to 48 hours after surgery. |
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Data not collected for this outcome measure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Intervention | 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. bevacizumab: 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 cisplatin: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles gemcitabine hydrochloride: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles paclitaxel: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles cysectomy | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Anderton | Medical University of South Carolina | 843-792-2708 | anderton@musc.edu |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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