Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA (NCT01893801) | Clinical Trial Compass
CompletedPhase 1/2
Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA
United States25 participantsStarted 2013-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 imagi…