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

NCT ID: NCT00268450

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-21
• Study Completion Date: 2012-04-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: 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

cisplatin

Intervention Type: DRUG

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

gemcitabine hydrochloride

Intervention Type: 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

Intervention Type: DRUG

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

cysectomy

Intervention Type: PROCEDURE

Interventions

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

Intervention Type: BIOLOGICAL

cisplatin

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

Intervention Type: DRUG

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

Intervention Type: DRUG

paclitaxel

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

Intervention Type: DRUG

cysectomy

Intervention Type: PROCEDURE

Other Intervention Names

avastin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew S. Kraft, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Gustavo Leone

Role: STUDY_CHAIR

Medical University of South Carolina, Hollings Cancer Center

Locations

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

McLeod Regional Medical Center

Florence, South Carolina, United States

Lowcountry Hematology and Oncology, PA

Mt. Pleasant, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

MUSC-AVF-3312

Identifier Type: -

Identifier Source: secondary_id

MUSC-HR-15537

Identifier Type: -

Identifier Source: secondary_id

GENENTECH-AVF-3312

Identifier Type: -

Identifier Source: secondary_id

MUSC-CTO-100892

Identifier Type: -

Identifier Source: secondary_id

CDR0000454937

Identifier Type: -

Identifier Source: org_study_id