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An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma of Urinary Tract, Urethral Carcinoma, Carcinoma of Ureter, Carcinoma of Renal Pelvis

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Trial Information

An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy


Inclusion Criteria:



- Histologically or cytologically confirmed transitional cell carcinoma of the bladder,
urethra, ureter, or renal pelvis

- 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 more than one prior systemic treatment regimen for metastatic disease

- 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 nonapproved 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 VEGF

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

Approximately 40 months

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13943

NCT ID:

NCT01282463

Start Date:

April 2011

Completion Date:

June 2015

Related Keywords:

  • Carcinoma of Urinary Tract
  • Urethral Carcinoma
  • Carcinoma of Ureter
  • Carcinoma of Renal Pelvis
  • Carcinoma, Renal Cell
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Urethral Neoplasms

Name

Location

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.Denver, Colorado  
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.Manhassaet, New York  
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.Greenbrae, California  94904
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.Stamford, Connecticut  06902
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.Jacksonville, Florida  32256
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.Bethesda, Maryland  20817
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.Minneapolis, Minnesota  55404
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.Las Vegas, Nevada  89169
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.Eugene, Oregon  97401
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.Greenville, South Carolina  29605
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Norfolk, Virginia  23502
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.Seattle, Washington  98133
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.Washington, District of Columbia  20007