Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234494
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2005-10-05
Brief Title:
Cisplatin Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer
Sponsor:
Christopher Sweeney MBBS
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Cisplatin Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer Hoosier Oncology Group GU04-75
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 mgm2 Day 1
Gemcitabine 1250 mgm2 Day 1 and 8
Bevacizumab 15 mgkg 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 mgkg 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 andor the creatinine rises above 20 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 3000mm3
Absolute neutrophil count ANC 1500 mm3
Platelet count 100000mm3
Hemoglobin 8 gdL may be transfused or receive erythropoietin support to maintain or exceed this level
INR 15
No full dosetherapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin
Hepatic
Total bilirubin of 15 mgdL
ALT 5 times upper limit of normal for subjects with documented liver metastases 25 times the upper limit of normal for subjects without evidence of liver metastases
Renal
Serum creatinine of 15 mgdL
Urine proteincreatinine ratio 10 at screening
Cardiovascular
No history of myocardial infarction or stroke within the last 6 months
No uncontrolled hypertension blood pressure of 160 systolic andor 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 ie atrial fibrillation or paroxysmal supraventricular tachycardia are eligible or clinically significant peripheral vascular disease
Pulmonary
Not specified
Cisplatin 70 mgm2 Day 1
Gemcitabine 1250 mgm2 Day 1 and 8
Bevacizumab 15 mgkg 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 mgkg 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 andor the creatinine rises above 20 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 3000mm3
Absolute neutrophil count ANC 1500 mm3
Platelet count 100000mm3
Hemoglobin 8 gdL may be transfused or receive erythropoietin support to maintain or exceed this level
INR 15
No full dosetherapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin
Hepatic
Total bilirubin of 15 mgdL
ALT 5 times upper limit of normal for subjects with documented liver metastases 25 times the upper limit of normal for subjects without evidence of liver metastases
Renal
Serum creatinine of 15 mgdL
Urine proteincreatinine ratio 10 at screening
Cardiovascular
No history of myocardial infarction or stroke within the last 6 months
No uncontrolled hypertension blood pressure of 160 systolic andor 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 ie atrial fibrillation or paroxysmal supraventricular tachycardia are eligible or clinically significant peripheral vascular disease
Pulmonary
Not specified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None