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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 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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00268450
Enrollment
21
Registered
2005-12-22
Start date
2005-09-21
Completion date
2012-04-30
Last updated
2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

transitional cell carcinoma of the bladder, stage III bladder cancer, stage II bladder cancer, recurrent bladder cancer

Brief 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. 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.

Interventions

BIOLOGICALbevacizumab

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

DRUGcisplatin

Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles

DRUGgemcitabine 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

DRUGpaclitaxel

After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles

PROCEDUREcysectomy

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Complete Remission RateFrom day of first treatment until after cycle 3

Secondary

MeasureTime frame
Urinary Cytogeniticsbaseline and week 12
Progression Free Survivalfrom first treatment until time of progression or death, whichever comes first
Urinary Survivin LevelsBaseline, week 6 and week 12
Percentage of Planned Dose Receivedfrom first treatment until end of week 12
Rate of Post-operative Complicationsfrom first treatment until up to 48 hours after surgery.
Median Overall Surivialfrom first treatment until death

Countries

United States

Participant flow

Participants by arm

ArmCount
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
21
Total21

Baseline characteristics

CharacteristicStudy Intervention
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
8 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
19 Participants
Region of Enrollment
United States
21 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Complete Remission Rate

Time frame: From day of first treatment until after cycle 3

Population: Data for this outcome measure was not collected

Secondary

Median Overall Surivial

Time frame: from first treatment until death

Population: Data for this outcome measure was not collected

Secondary

Percentage of Planned Dose Received

Time frame: from first treatment until end of week 12

Population: Data for this outcome measure was not collected

Secondary

Progression Free Survival

Time frame: from first treatment until time of progression or death, whichever comes first

Population: Data for this outcome measure was not collected

Secondary

Rate of Post-operative Complications

Time frame: from first treatment until up to 48 hours after surgery.

Population: Data for this outcome measure was not collected

Secondary

Urinary Cytogenitics

Time frame: baseline and week 12

Population: Data for this outcome measure was not collected

Secondary

Urinary Survivin Levels

Time frame: Baseline, week 6 and week 12

Population: Data for this outcome measure was not collected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026