AzTrials
AzTrials

Ovarian CancerPhase 2NCT00318370

Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy

A Phase 2 study testing Farletuzumab and Chemo Plus Far in people with Ovarian Cancer and Fallopian Tube Cancer, run by Morphotek at 20 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Farletuzumab and Chemo Plus Far
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
20 sitesin 2 countries
Study dates
May 2006to Jun 2010
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

  • Female subjects at least 18 years of age, with a histologically confirmed diagnosis of non-mucinous epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) in first relapse after a first remission of 6 to 18 months duration.
  • Subjects must have undergone surgery. Subjects must have received primary chemotherapy, including at least one platinum agent.
  • Subject is eligible for retreatment with the same chemotherapy regimen that was used to induce remission (Exception: may reduce the dose of or discontinue taxane if contraindicated due to neurotoxicity.)
  • CA125 must have been elevated prior to original chemotherapy.
  • CA125 must be elevated at the time of relapse.
  • Life expectancy greater than or equal to 6 months, as estimated by the investigator.
Show all 14Show fewer
  • Eastern Cooperative Oncology Group performance status of 0, 1 or 2
  • Subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after final MORAb-003 administration, unless surgically sterile.
  • Any significant concomitant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
  • Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
  • Absolute neutrophil count (ANC) ≥ 1.2 x 10e9/L
  • Platelet count ≥ 100 x 10e9/L
  • Hemoglobin ≥ 8 g/dL
  • Subject must be willing and able to provide written informed consent. Translations of informed consent information may be provided, subject to the local institutional review board's (IRB's) policy.

Who cannot join

  • Known central nervous system (CNS) tumor involvement.
  • Evidence of other active malignancy requiring treatment.
  • Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
  • Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Exception: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
  • Active serious systemic disease, including active bacterial or fungal infection.
  • Active hepatitis or HIV infection.
Show all 11Show fewer
  • Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, interleukin 1 receptor antagonist [IL-1RA] or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
  • Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.
  • Maintenance of first remission by taxane or other chemotherapeutic agent(s).
  • Initiation or planned initiation of cancer therapy not given to induce primary remission. Substitutions of agents materially similar to those used in the original regimen are permissible.
  • Breast-feeding, pregnant, or likely to become pregnant during the study.

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States18 sites

  • New York Oncology Hematology

    Albany, New York, 12206

  • Lehigh Valley Women's Cancer Center

    Allentown, Pennsylvania, 18104

  • Northern Virginia Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • The Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • Hematology and Oncology Specialists, LLC

    Covington, Louisiana, 70433

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Gynecology Oncology Research & Development

    Greenville, South Carolina, 29601

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • Jayne Gurtler, M.D.

    Metairie, Louisiana, 70006

  • Hematology and Oncology Specialists, LLC

    Metarie, Louisiana, 70006

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Peninsula Cancer Center

    Newport News, Virginia, 23601

  • South Texas Oncology & Hematology

    San Antonio, Texas, 78229

  • Sharp HealthCare

    San Diego, California, 92123

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Cooper University Hospital

    Voorhees Township, New Jersey, 08043

Other trials in United States

Germany2 sites

  • Krankenhaus Nordwest

    Frankfurt

  • Nationales Centrum fur Tumorerkrankungen

    Heidelberg

Other trials in Germany

About this study

Official title: A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.

Read the detailed description

MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if MORAb-003 can work either as a single agent

  1. to treat a CA125-only relapse, or
  2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and
  3. to prolong a second response to chemotherapy.
Being tested
Farletuzumab, Chemo Plus Far
Keywords
Ovarian Cancer, Primary Fallopian Tube Cancer, Peritoneal Cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

What participants receive

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

  • FarletuzumabDrug

    Also called MORAb-003, Far Only

    Weekly Farletuzumab infusions Dose dependent on dosing group

  • Chemo Plus FarDrug

    Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Study groups in NCT00318370
Study groupRoleWhat they receive
Far OnlyExperimentalFarletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Receives: Drug: Farletuzumab
Chemo Plus FarExperimentalChemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Receives: Drug: Chemo Plus Far

What is being measured

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

  1. Serologic Response (Change in CA125 Level)

    Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).

    Measured: Baseline to response (up to 30 weeks)

  2. Serologic Response (Change in Cancer Antigen [CA-125] Level)

    Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).

    Measured: Baseline to response (up to 27 weeks)

Secondary outcomes (5)

  1. Time to Serologic Response (Change in CA-125 Level)

    Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.

    Measured: Baseline to response (up to 27 weeks)

  2. Duration of Serologic Response (CA-125)

    Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being >2 X ULN on two occasions.

    Measured: Baseline to response (up to 44 months)

  3. Overall Response Rate

    The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, "complete response" (CR), "partial response" (PR), "stable disease" (SD), or "progressive disease" (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.

    Measured: Baseline to response (up to 44 months)

  4. Progression-free Survival (PFS)

    PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 >2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.

    Measured: Baseline to response (up to 44 months)

  5. Percentage of Participants Who Had a Prolongation of Remission

    Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator's assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.

    Measured: Baseline to response (up to 44 months)

Timeline

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

  1. First posted26 Apr 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionFeb 2010
  4. Study completionJun 2010

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00318370
Sponsor's protocol ID
MORAb-003-002
Status last verified
Sep 2015
First submitted
24 Apr 2006
Last updated
9 Sep 2015
Data monitoring committee
No

Publications

  • Armstrong DK, White AJ, Weil SC, Phillips M, Coleman RL. Farletuzumab (a monoclonal antibody against folate receptor alpha) in relapsed platinum-sensitive ovarian cancer. Gynecol Oncol. 2013 Jun;129(3):452-8. doi: 10.1016/j.ygyno.2013.03.002. Epub 2013 Mar 6.

    PubMed 23474348

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Farletuzumab and Chemo Plus Far in people with Ovarian Cancer and Fallopian Tube Cancer, run by Morphotek at 20 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 14 inclusion and 11 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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Germany. 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 15 Feb 2012). 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?

Serologic Response (Change in CA125 Level) (time frame: Baseline to response (up to 30 weeks)). 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 NCT00318370, 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 9 Sep 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in