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

NCT00318370 | Completed Phase 2 Results

• 1 other identifier: MORAb-003-002
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 20

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms

Keywords

Ovarian Cancer; Primary Fallopian Tube Cancer; Peritoneal Cancer

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline to response (up to 30 weeks)

• 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).

  Baseline to response (up to 27 weeks)

Secondary Outcomes (5)

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

  Baseline to response (up to 27 weeks)

• Duration of Serologic Response (CA-125)

  Baseline to response (up to 44 months)

• Overall Response Rate

  Baseline to response (up to 44 months)

• Progression-free Survival (PFS)

  Baseline to response (up to 44 months)

• Percentage of Participants Who Had a Prolongation of Remission

  Baseline to response (up to 44 months)

Study Arms (2)

Far Only

EXPERIMENTAL

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

Drug: Farletuzumab

Chemo Plus Far

EXPERIMENTAL

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

Interventions

Farletuzumab DRUG

Weekly Farletuzumab infusions Dose dependent on dosing group

Also known as: MORAb-003, Far Only

Far Only

Chemo Plus Far 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.

Chemo Plus Far

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Morphotek: lead

Study Sites (20)

Sharp HealthCare

San Diego, California, 92123, United States

Location

St. Vincent Gynecologic Oncology

Indianapolis, Indiana, 46260, United States

Location

Hematology and Oncology Specialists, LLC

Covington, Louisiana, 70433, United States

Location

Jayne Gurtler, M.D.

Metairie, Louisiana, 70006, United States

Location

Hematology and Oncology Specialists, LLC

Metarie, Louisiana, 70006, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, 08003, United States

Location

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Cooper University Hospital

Voorhees Township, New Jersey, 08043, United States

Location

New York Oncology Hematology

Albany, New York, 12206, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Lehigh Valley Women's Cancer Center

Allentown, Pennsylvania, 18104, United States

Location

Gynecology Oncology Research & Development

Greenville, South Carolina, 29601, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

South Texas Oncology & Hematology

San Antonio, Texas, 78229, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Northern Virginia Pelvic Surgery Associates

Annandale, Virginia, 22003, United States

Location

Peninsula Cancer Center

Newport News, Virginia, 23601, United States

Location

Krankenhaus Nordwest

Frankfurt, Germany

Location

Nationales Centrum fur Tumorerkrankungen

Heidelberg, Germany

Location

Related Publications (1)

• 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.

  PMID: 23474348 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Interventions

farletuzumab; Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Susan Weil, MD
• Organization: Morphotek, Inc.

sweil@morphotek.com

610-423-6182

Study Officials

• Susan C. Weil, M.D.

  Morphotek

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: May 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 9, 2015
• Results First Posted: February 15, 2012

Record last verified: 2015-09

Locations

DE (2); US (18)