Status:
COMPLETED
Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA
Lead Sponsor:
Pancreatic Cancer Research Team
Collaborating Sponsors:
Translational Genomics Research Institute
Honor Health - Clinical Trials
Conditions:
Stage IV Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (PDA).
Detailed Description
This is a phase 1b/2 open-label pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel, cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. ...
Eligibility Criteria
Inclusion
- Age \>18 years of age; male or female.
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- Capable of providing informed consent and complying with trial procedures.
- Karnofsky Performance Status (KPS) of \>/=70%.
- Life expectancy \>/=12 weeks.
- Measurable tumor lesions according to RECIST 1.1 criteria.
- Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
Exclusion
- Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
- Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
- Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
- History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for \>/= 5 years.
- Laboratory values: Screening serum creatinine \> upper limits of normal (ULN); total bilirubin \> ULN: alanine aminotransferase (ALT) and AST \>/= 2.5 ULN or \>/= 5.0 x ULN if liver metastases are present; absolute neutrophil count \< 1,500/mm3, platelet concentration \< 100,00/mm3, hematocrit level \< 27% for females or \< 30% for males, or coagulation tests (prothrombin time \[PT\], partial thromboplastin time \[PTT\], International Normalized Ratio \[INR\]) \> 1.5 x ULN unless on therapeutic doses of warfarin.
- current, serious, clinically significant cardiac arrhythmias as determined by the Investigator.
- History of HIV infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- Major surgery within 4 weeks prior to initiation of study treatment. Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
- Any condition that is unstable and could jeopardize the patient's participation in the study.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01893801
Start Date
May 1 2013
End Date
October 1 2017
Last Update
May 29 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Scottsdale Health Care
Scottsdale, Arizona, United States, 85260
2
Rutgers - Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, United States, 08901
3
Vita Medical Associates, PC
Bethlehem, Pennsylvania, United States, 18015