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

Stage IV Pancreatic Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893801
• Other study ID #: PCRT 12-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2013
• Est. completion date: October 1, 2017

Study information

• Verified date: May 2019
• Source: Pancreatic Cancer Research Team
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 Multiple cycles may be administered until the patient is withdrawn from therapy.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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 1, 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Stage IV Pancreatic Cancer

Intervention

Drug:
• nab-paclitaxel
25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
• Cisplatin
25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle
• gemcitabine
1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Locations

Country	Name	City	State
United States	Vita Medical Associates, PC	Bethlehem	Pennsylvania
United States	Rutgers - Cancer Institute of New Jersey (CINJ)	New Brunswick	New Jersey
United States	Scottsdale Health Care	Scottsdale	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Pancreatic Cancer Research Team	Cancer Research and Biostatistics Clinical Trials Consortium, Honor Health - Clinical Trials, Translational Genomics Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

2013 Gastrointestinal Cancers Symposium. Abstract LBA148. Presented January 25, 2013

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	The primary objectives of this study is to pursue treatment of 25 individual patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDA) to evaluate: Complete response rate as defined by computed tomography (CT) scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2x ULN). We expect to accomplish this in > or = to 5% of patients. When a complete response (CR) is documented, a confirmatory PET scan will be obtained.; If 1 or more of 10 patients demonstrate a complete response (CR), study will continue to enroll to a total of 25 patients.; If intolerable adverse events or no clinical benefit are noted in the first 6 patients, study will discontinue enrollment.	1 yr.
Secondary	Treatment-Related Toxicities	Frequency of treatment-related toxicities	Over the course of the subjects' treatment on study, approx 1 year
Secondary	Percentage Change in CA 19-9	Percentage change in CA 19-9 from baseline values	Over the course of the subjects' treatment on study, approx 1 year
Secondary	Overall Survival	Overall survival is defined as the time from study enrollment until death from any cause.	Over the course of the subjects' treatment and participation in study, approx 18 mos
Secondary	Progression-Free Survival	Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause.	Over the course of the subjects' treatment and participation in study, approx 18 mos

External Links

•   Additional information about the Pancreatic Cancer Research Team (PCRT)
•   Non-profit Organization
•   Non-profit organization for pancreatic cancer research
•   Related link