Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT00234494
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2005-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer
Sponsor:
Christopher Sweeney, MBBS
Organization:
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 mg/m2 Day 1
* Gemcitabine 1250 mg/m2 Day 1 and 8
* Bevacizumab 15 mg/kg 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 mg/kg 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 and/or the creatinine rises above 2.0, 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 \> 3000/mm3
* Absolute neutrophil count (ANC) \> 1500 mm/3
* Platelet count \> 100,000/mm3
* Hemoglobin \> 8 g/dL (may be transfused or receive erythropoietin support to maintain or exceed this level).
* INR \< 1.5
* No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin
Hepatic:
* Total bilirubin of \<1.5 mg/dL
* ALT \<5 times upper limit of normal for subjects with documented liver metastases; \<2.5 times the upper limit of normal for subjects without evidence of liver metastases.
Renal:
* Serum creatinine of \< 1.5 mg/dL.
* Urine protein:creatinine ratio \< 1.0 at screening
Cardiovascular:
* No history of myocardial infarction or stroke within the last 6 months
* No uncontrolled hypertension (blood pressure of \>160 systolic and/or 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, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease.
Pulmonary:
* Not specified
* Cisplatin 70 mg/m2 Day 1
* Gemcitabine 1250 mg/m2 Day 1 and 8
* Bevacizumab 15 mg/kg 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 mg/kg 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 and/or the creatinine rises above 2.0, 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 \> 3000/mm3
* Absolute neutrophil count (ANC) \> 1500 mm/3
* Platelet count \> 100,000/mm3
* Hemoglobin \> 8 g/dL (may be transfused or receive erythropoietin support to maintain or exceed this level).
* INR \< 1.5
* No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin
Hepatic:
* Total bilirubin of \<1.5 mg/dL
* ALT \<5 times upper limit of normal for subjects with documented liver metastases; \<2.5 times the upper limit of normal for subjects without evidence of liver metastases.
Renal:
* Serum creatinine of \< 1.5 mg/dL.
* Urine protein:creatinine ratio \< 1.0 at screening
Cardiovascular:
* No history of myocardial infarction or stroke within the last 6 months
* No uncontrolled hypertension (blood pressure of \>160 systolic and/or 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, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease.
Pulmonary:
* Not specified
Study Oversight
Has Oversight DMC:
True
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?: