Study of Ramucirumab in Ovarian Cancer

NCT00721162 | Completed Phase 2 Results DMC

• 4 other identifiers: 139232007-006717-17CP12-0711I4T-IE-JVBR
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 13

Brief Summary

The purpose of this study is to determine if ramucirumab given as monotherapy is effective in the treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

Ovarian Cancer,; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)

  Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.

  First Dose to 6 Months

• Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)

  Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.

  First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  First dose to measured progressive disease or death due to any cause up to 34.6 months

• Overall Survival at 1 Year (OS-1)

  First dose to 12 months

• Overall Survival (OS)

  First dose to death due to any cause up to 43.9 months

• Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events

  First dose to 30 months

Study Arms (1)

Ramucirumab

EXPERIMENTAL

Biological: Ramucirumab

Interventions

Ramucirumab BIOLOGICAL

Participants will receive ramucirumab at 8 milligrams/kilogram (mg/kg) administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Also known as: IMC-1121B

Ramucirumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant must meet the following criteria to be enrolled in this study:
• The participant has recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via a pathology report
• The participant has at least one unidimensional-measurable target lesion \[≥ 2 centimeter (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography (CT) or magnetic resonance imaging (MRI)\], as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• The participant has recovered to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to Grade ≤ 2). Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to the first dose of study medication, or hormonal therapy discontinued at least one week prior to the first dose of study medication. Continuation of hormone replacement therapy is permitted
• The participant has completed at least one platinum-based chemotherapeutic regimen for management of primary disease, and must have at least one of the following: a platinum-free interval of \< 12 months after the final dose of primary platinum-based therapy, progression during platinum-based therapy, or persistent disease after platinum-based therapy
• The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry
• The participant has adequate hematological functions \[absolute neutrophil count (ANC) ≥ 1200 cells/microliter (uL), hemoglobin ≥ 9 grams/deciliter (g/dL), and platelets ≥ 100,000 cells/uL\]
• The participant has adequate hepatic function \[bilirubin ≤ 1.5 times the upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 3.0 times ULN, or ≤ 5.0 times ULN if the transaminase elevation is due to liver metastases\]
• The participant has adequate renal function \[serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured or calculated) ≥ 60 milliliters/minute (mL/min)\]
• The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicated ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate \< 1000 milligrams (mg) of protein in 24 hours to allow participation in the study
• The participant has adequate coagulation function, as defined by international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic INR and have no active bleeding (defined as within 14 days of first dose of study medication) or pathological condition that carries a high risk of bleeding (example, tumor involving major vessels or known varices)
• For participants who have received anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within normal institutional range by a pretreatment echocardiogram or multigated acquisition (MUGA) scan
• If sexually active, the participant is post-menopausal, surgically sterile, or using effective contraception in the opinion of the investigator
• The participant is ≥ 18 years of age
• The participant has a life expectancy of ≥ 3 months

You may not qualify if:

• The participant has a concurrent active malignancy, other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible provided that she has been disease-free for \> 3 years
• The participant has received a noncytotoxic regimen (usually called targeted therapy such as bevacizumab) for recurrent or persistent disease. (Participants may have received a noncytotoxic regimen as primary treatment.)
• The participant has received radiotherapy for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of study medication
• The participant has received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last 3 years. \[Prior radiation for localized cancer (for example, of the breast, head and neck, or skin) is permitted, provided that it was completed \> 3 years prior to the first dose of study medication, and the participant remains free of recurrent or metastatic disease.\]
• The participant has received prior chemotherapy for any abdominal or pelvic tumor, other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer \< 3 years prior to the first dose of study medication. Prior adjuvant chemotherapy for localized breast cancer is permitted, provided that it was completed \>3 years prior to the first dose of study medication, and that the participant remains free of recurrent or metastatic disease
• The participant has undergone major abdominal surgery within 4 weeks (28 days) prior to first dose of study medication
• The participant has a suspected impending bowel obstruction, based on clinical or radiographic criteria
• The participant has received any hormonal therapy directed at the malignant tumor discontinued therapy within 1 week (7 days) prior to first dose of study medication
• The participant has received any other prior therapy directed at the malignant tumor, including immunologic agents, within 3 weeks (21 days) prior to first dose of study medication
• The participant has received previous treatment with ramucirumab
• The participant has participated in clinical trials of experimental agents within 4 weeks (28 days) prior to first dose of study medication
• The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
• The participant has an ongoing or active infection requiring systemic antibiotics, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, myocardial infarction \< 6 months, Grade ≥ 2 peripheral vascular disease, poorly controlled hypertension despite standard medical management poorly controlled thrombotic or hemorrhagic disorder, psychiatric illness or social situations that would limit compliance with study requirements, or any other serious uncontrolled medical disorders in the opinion of the investigator
• The participant has any history of brain metastases or leptomeningeal disease. Screening for central nervous system (CNS) involvement for testing asymptomatic participants is not required
• The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (13)

ImClone Investigational Site

Hollywood, Florida, 33021, United States

Location

ImClone Investigational Site

Orlando, Florida, 32806, United States

Location

ImClone Investigational Site

Chicago, Illinois, 60637, United States

Location

ImClone Investigational Site

Marrero, Louisiana, 70072, United States

Location

ImClone Investigational Site

Metairie, Louisiana, 70006, United States

Location

ImClone Investigational Site

Baltimore, Maryland, 21237, United States

Location

ImClone Investigational Site

Boston, Massachusetts, 02114-2621, United States

Location

ImClone Investigational Site

Rochester, Minnesota, 55905, United States

Location

ImClone Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

ImClone Investigational Site

Houston, Texas, 77030-4009, United States

Location

ImClone Investigational Site

Seattle, Washington, 98104, United States

Location

ImClone Investigational Site

London, SW3 6JJ, United Kingdom

Location

ImClone Investigational Site

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Penson RT, Moore KM, Fleming GF, Braly P, Schimp V, Nguyen H, Matulonis UA, Banerjee S, Haluska P, Gore M, Bodurka DC, Hozak RR, Joshi A, Xu Y, Schwartz JD, McGuire WP. A phase II study of ramucirumab (IMC-1121B) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Gynecol Oncol. 2014 Sep;134(3):478-85. doi: 10.1016/j.ygyno.2014.06.029. Epub 2014 Jul 10.

  PMID: 25016924 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Ramucirumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2015
• Last Updated: September 26, 2019
• Results First Posted: June 18, 2014

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (11); GB (2)