Status:
COMPLETED
Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy
Lead Sponsor:
Morphotek
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00318370
Start Date
May 1 2006
End Date
June 1 2010
Last Update
September 9 2015
Active Locations (20)
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1
Sharp HealthCare
San Diego, California, United States, 92123
2
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States, 46260
3
Hematology and Oncology Specialists, LLC
Covington, Louisiana, United States, 70433
4
Jayne Gurtler, M.D.
Metairie, Louisiana, United States, 70006