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

NCT ID: NCT00398086

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-01
• Study Completion Date: 2010-12-01

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.

Detailed Description

Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound, 130 nanometer particle form of paclitaxel designed to avoid the problems associated with solvents used in Taxol(Abraxane prescribing information 2005). Albumin has a number of properties that make it an attractive molecule to combine with paclitaxel. Albumin is a natural transporter of endogenous hydrophobic molecules such as water-insoluble vitamins and hormones (Vorum 1999)and albumin binding to the gp-60 receptor (albondin) initiates the caveolae-mediated endothelial transport of protein-bound and unbound plasma constituents (John et al 2003, Minshall et al 2003, Tiruppathi et al 1997).

This study consisted of a Phase 1 dose escalation phase, a Phase 2 treatment phase and a 24-month follow-up phase.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

100 mg/m^2

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Administered by intravenous infusion over 30 minutes.

Albumin-bound paclitaxel

Intervention Type: DRUG

Administered by intravenous infusion over 30 minutes.

125 mg/m^2

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Administered by intravenous infusion over 30 minutes.

Albumin-bound paclitaxel

Intervention Type: DRUG

Administered by intravenous infusion over 30 minutes.

150 mg/m^2

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Administered by intravenous infusion over 30 minutes.

Albumin-bound paclitaxel

Intervention Type: DRUG

Administered by intravenous infusion over 30 minutes.

Interventions

Gemcitabine

Administered by intravenous infusion over 30 minutes.

Intervention Type: DRUG

Albumin-bound paclitaxel

Administered by intravenous infusion over 30 minutes.

Intervention Type: DRUG

Other Intervention Names

Gemzar®; ABI-007; ABRAXANE®

Eligibility Criteria

Inclusion Criteria

• 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%).
• Patient has a Karnofsky performance status (KPS) greater or equal to 70 (Eastern Cooperative Oncology Group [ECOG] PS 0-1).
• Patient has one or more metastatic tumors measurable by computed tomography (CT) scan.
• Patient has been informed about the nature of study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Von Hoff, MD

Role: PRINCIPAL_INVESTIGATOR

Scottsdale Clinical Research Institute

Locations

University of Alabama at Birmingham Comprehensive Cancer Ctr

Birmingham, Alabama, United States

Scottsdale Healthcare/Virginia Pipe Cancer Institute

Scottsdale, Arizona, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Baltimore, Maryland, United States

Virigina Piper Cancer Institute

Minneapolis, Minnesota, United States

South Texas Oncology & Hematology

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21969517 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28774338 (View on PubMed)

Other Identifiers

CA040

Identifier Type: -

Identifier Source: org_study_id