Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer

NCT00398086 | Completed Phase 1 Results

• 1 other identifier: CA040
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

Brief Summary

To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.

Conditions

Metastatic Pancreatic Cancer

Keywords

Metastatic Pancreatic Cancer, Abraxane, Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose-limiting Toxicities

  A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3: * Grade 4 neutropenia lasting \>3 days in the absence of growth factor support; * Grade 4 neutropenia associated with fever \>38.5°C; * Any other Grade 4 hematological toxicity; * Grade 3 thrombocytopenia with hemorrhage; * Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen; * Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue.

  Cycle 1 (Days 1-28)

Secondary Outcomes (8)

• Number of Participants With Adverse Events (AE)

  Up to 25 months

• Percentage of Participants Who Achieved an Objective Confirmed Overall Response

  Up to approximately 4 years

• Percentage of Participants With Disease Control

  Up to approximately 4 years

• Progression-free Survival

  Up to approximately 4 years

• Duration of Response

  Up to approximately 4 years

Study Arms (3)

100 mg/m^2

EXPERIMENTAL

Participants received albumin-bound paclitaxel 100 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.

Drug: Gemcitabine; Drug: Albumin-bound paclitaxel

125 mg/m^2

EXPERIMENTAL

Participants received albumin-bound paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.

Drug: Gemcitabine; Drug: Albumin-bound paclitaxel

150 mg/m^2

EXPERIMENTAL

Participants received albumin-bound paclitaxel 150 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.

Drug: Gemcitabine; Drug: Albumin-bound paclitaxel

Interventions

Gemcitabine DRUG

Administered by intravenous infusion over 30 minutes.

Also known as: Gemzar®

100 mg/m^2; 125 mg/m^2; 150 mg/m^2

Albumin-bound paclitaxel DRUG

Administered by intravenous infusion over 30 minutes.

Also known as: ABI-007, ABRAXANE®

100 mg/m^2; 125 mg/m^2; 150 mg/m^2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
• Male or non-pregnant and non-lactating female, and age greater or equal to 18.
• If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test beta-human chorionic gonadotropin (B-hCG) documented within 72 hours of the first administration of study drug.
• If sexually active, the patient must agree to use contraception considered adequate and appropriate by the investigator.
• Patient must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a patient received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at least 6 months after completing the last dose of gemcitabine.
• Patient has the following blood counts at baseline
• Absolute neutrophil count (ANC) equal or greater to 1.5 x 10\^9/L;
• Platelets equal or greater to 100 x 10\^9/L
• Hemoglobin equal or greater to 9 g/dL.
• Patient has the following blood chemistry levels at baseline:
• Aspartate aminotransferase (SGOT), Alanine aminotransferase (SGPT) equal or less than 2.5 x upper limit of normal range (ULN) is allowed
• Bilirubin less than or equal to ULN
• Serum creatinine within normal limits or calculated clearance equal or greater to 60 mL/min/1.73M\^2 patients with serum creatinine levels above the institutional normal value
• Patient has no clinically significant abnormalities in urinalysis results
• Patient has acceptable coagulation status as indicated by a prothrombin time (PT) within normal limits (plus or minus 15%) and partial thromboplastin time (PTT) within normal limits (plus or minus 15%).

You may not qualify if:

• Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart).
• Patient uses therapeutic coumadin for a history of pulmonary emboli and deep vein thrombosis (DVT).
• Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Patient has known infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C.
• Patient has undergone major surgery, other than diagnostic surgery i.e.-- done to obtain a biopsy for diagnosis without removal of an organ), with 4 weeks prior to Day 1 of treatment in this study.
• Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 3 weeks prior to study entry weeks (6 weeks for nitrosureas or mitomycin C).
• Patient has a history of allergy or hypersensitivity to the study drug.
• Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
• Patient is unwilling or unable to comply with study procedures.
• Patient is enrolled in any other clinical protocol or investigational trial.

Sponsors & Collaborators

• Celgene: lead

Study Sites (5)

University of Alabama at Birmingham Comprehensive Cancer Ctr

Birmingham, Alabama, United States

Location

Scottsdale Healthcare/Virginia Pipe Cancer Institute

Scottsdale, Arizona, 85258, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Baltimore, Maryland, 35233, United States

Location

Virigina Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

South Texas Oncology & Hematology

San Antonio, Texas, 78258, United States

Location

Related Publications (2)

• 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.

  PMID: 21969517 BACKGROUND

• Korn RL, Von Hoff DD, Borad MJ, Renschler MF, McGovern D, Curtis Bay R, Ramanathan RK. 18F-FDG PET/CT response in a phase 1/2 trial of nab-paclitaxel plus gemcitabine for advanced pancreatic cancer. Cancer Imaging. 2017 Aug 3;17(1):23. doi: 10.1186/s40644-017-0125-5.

  PMID: 28774338 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Daniel Von Hoff, MD

  Scottsdale Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 10, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2010
• Last Updated: November 22, 2019
• Results First Posted: August 21, 2013

Record last verified: 2019-11

Locations

US (5)