Status:
COMPLETED
Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer
Lead Sponsor:
Celgene
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.
Detailed Description
Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound, 130 nanometer particle form of paclitaxel designed to avoid the problems associated with solvents used in Taxol(Abraxane prescribing i...
Eligibility Criteria
Inclusion
- Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
- Male or non-pregnant and non-lactating female, and age greater or equal to 18.
- If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test beta-human chorionic gonadotropin (B-hCG) documented within 72 hours of the first administration of study drug.
- If sexually active, the patient must agree to use contraception considered adequate and appropriate by the investigator.
- Patient must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a patient received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at least 6 months after completing the last dose of gemcitabine.
- Patient has the following blood counts at baseline
- Absolute neutrophil count (ANC) equal or greater to 1.5 x 10\^9/L;
- Platelets equal or greater to 100 x 10\^9/L
- Hemoglobin equal or greater to 9 g/dL.
- Patient has the following blood chemistry levels at baseline:
- Aspartate aminotransferase (SGOT), Alanine aminotransferase (SGPT) equal or less than 2.5 x upper limit of normal range (ULN) is allowed
- Bilirubin less than or equal to ULN
- Serum creatinine within normal limits or calculated clearance equal or greater to 60 mL/min/1.73M\^2 patients with serum creatinine levels above the institutional normal value
- Patient has no clinically significant abnormalities in urinalysis results
- Patient has acceptable coagulation status as indicated by a prothrombin time (PT) within normal limits (plus or minus 15%) and partial thromboplastin time (PTT) within normal limits (plus or minus 15%).
- Patient has a Karnofsky performance status (KPS) greater or equal to 70 (Eastern Cooperative Oncology Group \[ECOG\] PS 0-1).
- Patient has one or more metastatic tumors measurable by computed tomography (CT) scan.
- Patient has been informed about the nature of study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Exclusion
- Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart).
- Patient uses therapeutic coumadin for a history of pulmonary emboli and deep vein thrombosis (DVT).
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C.
- Patient has undergone major surgery, other than diagnostic surgery i.e.-- done to obtain a biopsy for diagnosis without removal of an organ), with 4 weeks prior to Day 1 of treatment in this study.
- Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 3 weeks prior to study entry weeks (6 weeks for nitrosureas or mitomycin C).
- Patient has a history of allergy or hypersensitivity to the study drug.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
- Patient is unwilling or unable to comply with study procedures.
- Patient is enrolled in any other clinical protocol or investigational trial.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00398086
Start Date
November 1 2006
End Date
December 1 2010
Last Update
November 22 2019
Active Locations (5)
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1
University of Alabama at Birmingham Comprehensive Cancer Ctr
Birmingham, Alabama, United States
2
Scottsdale Healthcare/Virginia Pipe Cancer Institute
Scottsdale, Arizona, United States, 85258
3
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 35233
4
Virigina Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407