An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00570713
- Lead Sponsor
- Morphotek
- Brief Summary
The purpose of this study is to investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
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Female or male subjects, ≥ 18 years of age, with cytologically or histologically confirmed diagnosis of pancreatic adenocarcinoma.
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Must have measurable disease, as defined by RECIST or evaluable by clinical signs/symptoms (e.g. ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
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Must have unresectable disease and have received no prior chemotherapy or radiation therapy for their pancreatic cancer.
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Karnofsky performance status of greater than or equal to 70 %.
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Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
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Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
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Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Serum bilirubin ≤ 2.0 mg/dL Aspartate transaminase (AST)* ≤ 5 x upper limit of normal (ULN) Alanine transaminase (ALT)* ≤ 5 x ULN Alkaline phosphatase* ≤ 5 x ULN Serum creatinine ≤ 2.0 mg/dL Stenting to reduce liver functions to qualifying levels is permitted.
* Subjects with liver function abnormalities greater than the ULN are eligible only if in the opinion of the investigator they are due to disease obstruction of the bile ducts or metastatic disease.
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Must be willing and able to provide written informed consent.
- 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 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
- Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: 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 viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
- Prior chemotherapy or radiation therapy for their pancreatic cancer.
- Breast-feeding, pregnant, or likely to become pregnant during the study.
- No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
- Known hypersensitivity to a monoclonal antibody or biologic therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo plus gemcitabine ('Placebo') Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. MORAb-009 MORAb-009 MORAb-009 plus gemcitabine ('MORAb-009'): MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. MORAb-009 Gemcitabine MORAb-009 plus gemcitabine ('MORAb-009'): MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. Placebo Gemcitabine Placebo plus gemcitabine ('Placebo') Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 1-21 Months This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.
- Secondary Outcome Measures
Name Time Method Progression-free Survival 1-21 Months Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.
Best Overall Response Rate Baseline to response up to 21 months Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.
Trial Locations
- Locations (45)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates, PA
🇺🇸Columbia, South Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
South Texas Onocology Hemotology, PA
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin Clinical Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Carle Clinic Assoc.
🇺🇸Urbana, Illinois, United States
Palm Beach Institute of Hematology and Oncology
🇺🇸Boynton Beach, Florida, United States
Hematology-Oncology Associates of Illinois, LLC
🇺🇸Skokie, Illinois, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Kaiser Permanente
🇺🇸Vallejo, California, United States
Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD
🇺🇸Metairie, Louisiana, United States
The Center for Cancer and Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
Services de gastro-entérologie et d'oncologie, CHC Saint-Joseph
🇧🇪Liege, Belgium
II. Medizinische Klinik des Klinikums rechts der Isar
🇩🇪München, Bayern, Germany
Charité, Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Arena Oncology Associates, P.C.
🇺🇸Lake Success, New York, United States
Centre Hospitalier Jolimont-Lobbes
🇧🇪Haine Saint Paul, Hainaut, Belgium
Hanover Medical Specialists, MD
🇺🇸Wilmington, North Carolina, United States
Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg
🇩🇪Freiburg, Baden Wurttemburg, Germany
Cancer Center of Central Connecticut
🇺🇸Southington, Connecticut, United States
Providence Cancer Center, Oncology, Clinical Trials
🇺🇸Southfield, Michigan, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Connecticut Oncology & Hematology
🇺🇸Torrington, Connecticut, United States
Providence Western Washington Oncology
🇺🇸Lacey, Washington, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Universitätsklinikum Ulm, Innere Medizin I
🇩🇪Ulm, Baden Wurttemburg, Germany
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden Wurttemburg, Germany
Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie
🇩🇪Bielefeld, Nordrhein-Westfalen, Germany
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Madrid
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hematology Oncology Associates of the Palm Beaches
🇺🇸Lake Worth, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Hospital Clinico Universitario San Carlos
🇪🇸Madrid, Spain
SLK-Kliniken Heilbronn GmbH, Medizinische Klinik III
🇩🇪Heilbronn, Baden Wurttemburg, Germany
London Regional Cancer Program London Health Sciences Centre
🇨🇦London, Ontario, Canada
AZ Sint Maarten - digestive oncology unit - campus
🇧🇪Mechelen, Belgium
University of Kansas Medical Center
🇺🇸Westwood, Kansas, United States