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

NCT ID: NCT00318370

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-06-30

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Far Only

Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).

Group Type: EXPERIMENTAL

Farletuzumab

Intervention Type: DRUG

Weekly Farletuzumab infusions Dose dependent on dosing group

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.

Group Type: EXPERIMENTAL

Chemo Plus Far

Intervention Type: DRUG

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.

Interventions

Farletuzumab

Weekly Farletuzumab infusions Dose dependent on dosing group

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MORAb-003; Far Only

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Morphotek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan C. Weil, M.D.

Role: STUDY_DIRECTOR

Morphotek

Locations

Sharp HealthCare

San Diego, California, United States

St. Vincent Gynecologic Oncology

Indianapolis, Indiana, United States

Hematology and Oncology Specialists, LLC

Covington, Louisiana, United States

Jayne Gurtler, M.D.

Metairie, Louisiana, United States

Hematology and Oncology Specialists, LLC

Metarie, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, United States

The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Cooper University Hospital

Voorhees Township, New Jersey, United States

New York Oncology Hematology

Albany, New York, United States

Gabrail Cancer Center

Canton, Ohio, United States

Lehigh Valley Women's Cancer Center

Allentown, Pennsylvania, United States

Gynecology Oncology Research & Development

Greenville, South Carolina, United States

Mary Crowley Medical Research Center

Dallas, Texas, United States

South Texas Oncology & Hematology

San Antonio, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Northern Virginia Pelvic Surgery Associates

Annandale, Virginia, United States

Peninsula Cancer Center

Newport News, Virginia, United States

Krankenhaus Nordwest

Frankfurt, , Germany

Nationales Centrum fur Tumorerkrankungen

Heidelberg, , Germany

Countries

United States; Germany

References

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.

Reference Type: DERIVED

PMID: 23474348 (View on PubMed)

Other Identifiers

MORAb-003-002

Identifier Type: -

Identifier Source: org_study_id