Clinical trial NCT00318370: Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy
Official title: A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Keywords: Ovarian Cancer
Primary Fallopian Tube Cancer
Peritoneal Cancer
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2006-04-26
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Serologic Response (Change in CA125 Level)
timeFrame: Baseline to response (up to 30 weeks)
measure: Serologic Response (Change in Cancer Antigen [CA-125] Level)
timeFrame: Baseline to response (up to 27 weeks)
Secondary outcomes:
measure: Time to Serologic Response (Change in CA-125 Level)
timeFrame: Baseline to response (up to 27 weeks)
measure: Duration of Serologic Response (CA-125)
timeFrame: Baseline to response (up to 44 months)
measure: Overall Response Rate
timeFrame: Baseline to response (up to 44 months)
measure: Progression-free Survival (PFS)
timeFrame: Baseline to response (up to 44 months)
measure: Percentage of Participants Who Had a Prolongation of Remission
timeFrame: Baseline to response (up to 44 months)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp HealthCare
state: California
city: Indianapolis
country: United States
facility: St. Vincent Gynecologic Oncology
state: Indiana
city: Covington
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Metairie
country: United States
facility: Jayne Gurtler, M.D.
state: Louisiana
city: Metarie
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Voorhees
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Women's Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Gynecology Oncology Research & Development
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology & Hematology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Annandale
country: United States
facility: Northern Virginia Pelvic Surgery Associates
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Center
state: Virginia
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Heidelberg
country: Germany
facility: Nationales Centrum fur Tumorerkrankungen
Study officials:
affiliation: Morphotek
name: Susan C. Weil, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.