Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gayle Jameson; Pancreatic Cancer Research Team
• Collaborators: Cancer Research and Biostatistics Clinical Trials Consortium; Honor Health - Clinical Trials; Translational Drug Development; Translational Genomics Research Institute; Virgina G. Piper Cancer Center - Clinical Trials
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Paclitaxel

Criteria

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 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.