Study of Ramucirumab or IMC-18F1 With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01282463
First received: January 21, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3 treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and IMC-18F1.


Condition Intervention Phase
Carcinoma of Urinary Tract
Urethral Carcinoma
Carcinoma of Ureter
Carcinoma of Renal Pelvis
Drug: Docetaxel
Biological: Ramucirumab DP
Biological: IMC-18F1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of placental growth factor (PlGF) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of vascular endothelial growth factor-A (VEGF-A) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of vascular endothelial growth factor-B (VEGF-B) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of soluble vascular endothelial growth factor-1 (VEGFR-1) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of soluble vascular endothelial growth factor-2 (VEGFR-2) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Serum Anti-Ramucirumab Antibody Assessment [ Time Frame: Approximately 40 months ] [ Designated as safety issue: Yes ]
  • Serum Anti-18F1 Antibody Assessment [ Time Frame: Approximately 40 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 138
Study Start Date: April 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Drug: Docetaxel
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Experimental: Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Drug: Docetaxel
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Biological: Ramucirumab DP
Ramucirumab (DP): 10 mg/kg I.V. on day 1 of each 21-day cycle
Other Names:
  • IMC-1121B
  • LY3009806
Experimental: Docetaxel + IMC-18F1
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Drug: Docetaxel
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Biological: IMC-18F1
12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle
Other Names:
  • Icrucumab
  • LY3012212

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01282463

  Show 32 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01282463     History of Changes
Other Study ID Numbers: 13943, CP20-0902, I4Y-IE-JCDC
Study First Received: January 21, 2011
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Eli Lilly and Company:
Carcinoma, Renal Cell

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014