Clinical trial NCT01893801: Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA
Official title: A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stage IV Pancreatic Cancer
Keywords: pancreatic cancer
pancreatic adenocarcinoma
Stage IV pancreatic cancer
pancreas
pancreatic
Lead sponsor: Pancreatic Cancer Research Team
Sponsor class: OTHER
Collaborators: name: Translational Genomics Research Institute
name: Honor Health - Clinical Trials
name: Cancer Research and Biostatistics Clinical Trials Consortium
First posted: 2013-07-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy.

Overall response rates as well as individual categories of response (complete response-CR, partial response-PR, stable disease-SD and progressive disease-PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression free survival (PFS) and OS (overall survival) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE (v4.0, May 2009).

Eligibility 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.

Primary outcomes:
measure: Complete Response Rate
timeFrame: 1 yr.
Secondary outcomes:
measure: Treatment-Related Toxicities
timeFrame: Over the course of the subjects' treatment on study, approx 1 year
measure: Percentage Change in CA 19-9
timeFrame: Over the course of the subjects' treatment on study, approx 1 year
measure: Overall Survival
timeFrame: Over the course of the subjects' treatment and participation in study, approx 18 mos
measure: Progression-Free Survival
timeFrame: Over the course of the subjects' treatment and participation in study, approx 18 mos
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Health Care
state: Arizona
city: New Brunswick
country: United States
facility: Rutgers - Cancer Institute of New Jersey (CINJ)
state: New Jersey
city: Bethlehem
country: United States
facility: Vita Medical Associates, PC
state: Pennsylvania
Study officials:
affiliation: Scottsdale Health Care
name: Gayle S Jameson, MSN ACNP-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.
citation: 2013 Gastrointestinal Cancers Symposium. Abstract LBA148. Presented January 25, 2013
citation: Jameson GS, Borazanci E, Babiker HM, Poplin E, Niewiarowska AA, Gordon MS, Barrett MT, Rosenthal A, Stoll-D'Astice A, Crowley J, Shemanski L, Korn RL, Ansaldo K, Lebron L, Ramanathan RK, Von Hoff DD. Response Rate Following Albumin-Bound Paclitaxel Plus Gemcitabine Plus Cisplatin Treatment Among Patients With Advanced Pancreatic Cancer: A Phase 1b/2 Pilot Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):125-132. doi: 10.1001/jamaoncol.2019.3394.