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Ovarian CancerPhase 2NCT00721162

Study of Ramucirumab in Ovarian Cancer

A Phase 2 study testing Ramucirumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Eli Lilly and Company at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ramucirumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
13 sitesin 2 countries
Study dates
Aug 2008to Aug 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • The participant is able to provide informed written consent and is amenable to compliance with protocol schedules and testing

Who cannot join

  • 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
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  • 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
  • The participant is pregnant [confirmed by serum beta human chorionic gonadotropin (β-HCG) test] or lactating

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States11 sites

  • ImClone Investigational Site

    Baltimore, Maryland, 21237

  • ImClone Investigational Site

    Boston, Massachusetts, 02114-2621

  • ImClone Investigational Site

    Chicago, Illinois, 60637

  • ImClone Investigational Site

    Hollywood, Florida, 33021

  • ImClone Investigational Site

    Houston, Texas, 77030-4009

  • ImClone Investigational Site

    Marrero, Louisiana, 70072

  • ImClone Investigational Site

    Metairie, Louisiana, 70006

  • ImClone Investigational Site

    Oklahoma City, Oklahoma, 73104

  • ImClone Investigational Site

    Orlando, Florida, 32806

  • ImClone Investigational Site

    Rochester, Minnesota, 55905

  • ImClone Investigational Site

    Seattle, Washington, 98104

Other trials in United States

United Kingdom2 sites

  • ImClone Investigational Site

    London, SW3 6JJ

  • ImClone Investigational Site

    Sutton, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase 2, Non-randomized, Open-label, Multicenter Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

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.

Read the detailed description

Current chemotherapies used to treat ovarian cancer participants include doxorubicin, topotecan, and paclitaxel, to mention a few. Doxorubicin was studied in ovarian cancer participants that were refractory to paclitaxel and platinum-based chemotherapy agents. Inhibition of angiogenesis is considered a promising approach to the treatment of cancer. Vascular endothelial growth factor (VEGF) is an important regulator of angiogenesis and is likely an important therapeutic target in persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. VEGF is overexpressed in ovarian tissue and may be the most important single tumor angiogenic factor. Phase 1 studies currently nearing completion with ramucirumab have demonstrated safety and tolerability at clinically relevant doses, with preliminary evidence of clinical efficacy in ovarian cancer participants. Therefore, ImClone Systems plans to conduct a Phase 2 trial to assess the safety and efficacy of ramucirumab in participants with platinum-refractory persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

Being tested
Ramucirumab
Keywords
Ovarian Cancer,, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamucirumabBiological

    Also called IMC-1121B

    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.

Study groups in NCT00721162
Study groupRoleWhat they receive
RamucirumabExperimentalNot described
Receives: Biological: Ramucirumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: First Dose to 6 Months

  2. 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.

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

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. 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. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.

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

  2. Overall Survival at 1 Year (OS-1)

    Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.

    Measured: First dose to 12 months

  3. Overall Survival (OS)

    Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.

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

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

    Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.

    Measured: First dose to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionMay 2012
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00721162
Sponsor's protocol ID
13923
Other IDs
2007-006717-17, CP12-0711, I4T-IE-JVBR
Status last verified
Sep 2019
First submitted
21 Jul 2008
Last updated
26 Sep 2019
Data monitoring committee
Yes
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • 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.

    PubMed 25016924

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramucirumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Eli Lilly and Company at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6) (time frame: First Dose to 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00721162, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.

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