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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00318370
First received: April 24, 2006
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Drug: Farletuzumab
Drug: Chemo Plus Far
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Serologic Response (Change in CA125 Level) [ Time Frame: Baseline to response (up to 30 weeks) ] [ Designated as safety issue: No ]
    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).

  • Serologic Response (Change in Cancer Antigen [CA-125] Level) [ Time Frame: Baseline to response (up to 27 weeks) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Time to Serologic Response (Change in CA-125 Level) [ Time Frame: Baseline to response (up to 27 weeks) ] [ Designated as safety issue: No ]
    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.

  • Duration of Serologic Response (CA-125) [ Time Frame: Baseline to response (up to 44 months) ] [ Designated as safety issue: No ]
    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.

  • Overall Response Rate [ Time Frame: Baseline to response (up to 44 months) ] [ Designated as safety issue: No ]
    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.

  • Progression-free Survival (PFS) [ Time Frame: Baseline to response (up to 44 months) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Had a Prolongation of Remission [ Time Frame: Baseline to response (up to 44 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 58
Study Start Date: May 2006
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Far Only
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Drug: Farletuzumab
Weekly Farletuzumab infusions Dose dependent on dosing group
Other Names:
  • MORAb-003
  • Far Only
Experimental: Chemo Plus Far
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.
Drug: Chemo Plus Far
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.

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.
  Eligibility

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

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318370

Locations
United States, California
Sharp HealthCare
San Diego, California, United States, 92123
United States, Indiana
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Hematology and Oncology Specialists, LLC
Covington, Louisiana, United States, 70433
Jayne Gurtler, M.D.
Metairie, Louisiana, United States, 70006
Hematology and Oncology Specialists, LLC
Metarie, Louisiana, United States, 70006
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, New Jersey
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Cooper University Hospital
Voorhees, New Jersey, United States, 08043
United States, New York
New York Oncology Hematology
Albany, New York, United States, 12206
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Pennsylvania
Lehigh Valley Women's Cancer Center
Allentown, Pennsylvania, United States, 18104
United States, South Carolina
Gynecology Oncology Research & Development
Greenville, South Carolina, United States, 29601
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
South Texas Oncology & Hematology
San Antonio, Texas, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, United States, 22003
Peninsula Cancer Center
Newport News, Virginia, United States, 23601
Germany
Krankenhaus Nordwest
Frankfurt, Germany
Nationales Centrum fur Tumorerkrankungen
Heidelberg, Germany
Sponsors and Collaborators
Morphotek
Investigators
Study Director: Susan C. Weil, M.D. Morphotek, Inc.
  More Information

No publications provided by Morphotek

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00318370     History of Changes
Other Study ID Numbers: MORAb-003-002
Study First Received: April 24, 2006
Results First Received: January 27, 2012
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
Ovarian Cancer
Primary Fallopian Tube Cancer
Peritoneal Cancer

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on September 14, 2014