Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT00844649
- Lead Sponsor
- Celgene
- Brief Summary
Phase III Metastatic Pancreatic Cancer
- Detailed Description
A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 861
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Albumin-bound paclitaxel (ABI-007)/Gemcitabine Gemcitabine ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. Albumin-bound paclitaxel (ABI-007)/Gemcitabine Albumin-bound paclitaxel (ABI-007) ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. Gemcitabine Gemcitabine Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months. Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) by Independent Radiological Review (IRR) Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months. Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Trial Locations
- Locations (191)
UAB Comprenhensive Cancer Center at University of Alabama
🇺🇸Birmingham, Alabama, United States
Clearview Cancer Institute Oncology Specialities, P.C.
🇺🇸Huntsville, Alabama, United States
TGEN Clinical Research Services at Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic-Scottsdale
🇺🇸Scottsdale, Arizona, United States
Northern Arizona Hematology and Oncology Associates-AOA
🇺🇸Sedona, Arizona, United States
Arizona Cancer Center, University of Arizona
🇺🇸Tucson, Arizona, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
City of Hope
🇺🇸Duarte, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
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