Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma
NCT ID: NCT01282463
Last Updated: 2019-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2011-04-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel
Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel
Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
Ramucirumab DP
Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel
Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
Icrucumab
12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle
Interventions
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Docetaxel
Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
Ramucirumab DP
Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle
Icrucumab
12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Locally advanced or metastatic and unresectable transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
* Had treatment with a platinum-containing regimen
* Disease progression within 12 months of after receiving the last dose of a platinum containing regimen in the neoadjuvant or adjuvant setting, and/or had disease progression while on a platinum-containing regimen or within 12 months after the last dose of therapy in the locally advanced or metastatic setting
* Has measurable or nonmeasurable disease
* Life expectancy of ≥ 3 months
* Received no more than 2 prior systemic chemotherapy regimens in any setting
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Has adequate hematologic, coagulation, hepatic and renal function
* Does not have:
* cirrhosis at a level of Child-Pugh B (or worse)
* cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
* If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 12 weeks after the treatment period
* If male, the patient is surgically sterile or compliant with a contraceptive regimen during and for 12 weeks after the treatment period
Exclusion Criteria
* Received prior systemic taxane therapy (except for prior paclitaxel therapy) for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant, metastatic). Prior intravesical taxane therapy is allowed
* Has received more than one prior anti-angiogenic agent for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis
* Has received radiation therapy within 4 weeks prior to randomization
* Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
* Has experienced a Grade ≥ 3 bleeding event (eg, via gastric ulcers, gastric varices, or gross hematuria) within 3 months prior to randomization
* Has uncontrolled intercurrent illness including, but not limited to symptomatic anemia, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
* Has experienced any arterial thrombotic or thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack or cerebrovascular accident, within 6 months prior to randomization
* Has known brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
* Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
* Has known human immunodeficiency virus infection or acquired immunodeficiency syndrome
* Has received a prior autologous or allogeneic organ or tissue transplantation
* Received chemotherapy within 21 days prior to randomization; and/or is currently enrolled in, or discontinued within 21 days prior to randomization from, a clinical trial involving an investigational product or unapproved use of a drug or device (other than the study drug\[s\] used in this study), or is concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study; and/or was treated with anti-angiogenic therapy within 28 days prior to randomization
* Has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
* Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
* Has an elective or planned major surgery to be performed during the course of the trial
* Is pregnant or lactating
* Has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer, curatively treated cervical carcinoma in-situ, other noninvasive carcinoma or in-situ neoplasm, or prostate cancer with an undetectable prostate specific antigen (PSA) and no current treatment with hormone therapy
* Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
* History of gastrointestinal perforation and/or fistula within 6 months prior to randomization
* Has active diverticulitis
* Known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
* Known hypersensitivity to agents of similar biologic composition as ramucirumab DP, IMC-18F1, or other agents that specifically target vascular endothelial growth factor receptor (VEGF)
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Baltimore, Maryland, United States
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Rochester, Minnesota, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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New York, New York, United States
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Springfield, Oregon, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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McAllen, Texas, United States
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The Woodlands, Texas, United States
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Webster, Texas, United States
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Fairfax, Virginia, United States
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Hampton, Virginia, United States
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Seattle, Washington, United States
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Wenatchee, Washington, United States
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
Countries
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References
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Petrylak DP, Tagawa ST, Kohli M, Eisen A, Canil C, Sridhar SS, Spira A, Yu EY, Burke JM, Shaffer D, Pan CX, Kim JJ, Aragon-Ching JB, Quinn DI, Vogelzang NJ, Tang S, Zhang H, Cavanaugh CT, Gao L, Kauh JS, Walgren RA, Chi KN. Docetaxel As Monotherapy or Combined With Ramucirumab or Icrucumab in Second-Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma: An Open-Label, Three-Arm, Randomized Controlled Phase II Trial. J Clin Oncol. 2016 May 1;34(13):1500-9. doi: 10.1200/JCO.2015.65.0218. Epub 2016 Feb 29.
Other Identifiers
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CP20-0902
Identifier Type: OTHER
Identifier Source: secondary_id
I4Y-IE-JCDC
Identifier Type: OTHER
Identifier Source: secondary_id
13943
Identifier Type: -
Identifier Source: org_study_id
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