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A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas


Phase 3
18 Years
79 Years
Open (Enrolling)
Both
Metastatic Pancreatic Cancer

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Trial Information

A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas


A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound
Paclitaxel)in combination with gemcitabine administered weekly to standard treatment
(gemcitabine monotherapy) with respect to overall survival, objective tumor response rate
and PFS in patients diagnosed with metastatic adenocarcinoma of the pancreas.

Inclusion Criteria


Inclusion Criteria

A patient will be eligible for inclusion in this study only if all of the following
criteria are met:

1. Patient has definitive histologically or cytologically confirmed metastatic
adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic
adenocarcinoma will be made by integrating the histopathological data within the
context of the clinical and radiographic data. Patients with islet cell neoplasms are
excluded.

2. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to
randomization in the study.

3. Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient
is allergic to CT contrast media).

4. Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female
patient is of child-bearing potential, as evidenced by regular menstrual periods, she
must have a negative serum pregnancy test (β-hCG) documented 72 hours prior to the
first administration of study drug.

If sexually active, the patient must agree to use contraception considered
adequate and appropriate by the Investigator during the period of administration of
study drug. In addition, male and female patients must utilize contraception after
the end of treatment as recommended in the product's Summary of Product
Characteristics or Prescribing Information provided in the study manual.

5. Patients must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for the treatment of metastatic disease. Prior treatment with
5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is
allowed, provided at least 6 months have elapsed since completion of the last dose
and no lingering toxicities are present. Patients having received cytotoxic doses of
gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for
this study.

6. Patient has adequate biological parameters as demonstrated by the following blood
counts at Baseline (obtained ≤14 days prior to randomization):

Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100,000/mm3 (100 ×
109/L); Hemoglobin (Hgb) ≥ 9 g/dL.

7. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior
to randomization):

AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver
metastases are clearly present, then ≤ 5 × ULN is allowed Total bilirubin ≤ ULN Serum
creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m2 for
patients with serum creatinine levels above or below the institutional normal value.
If using creatinine clearance, actual body weight should be used for calculating
creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a
Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead.

8. Patient has acceptable coagulation studies (obtained ≤14 days prior to randomization)
as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within
normal limits (± 15%). (See also Section 6.2 for Baseline PT/PTT analysis).

9. Patient has no clinically significant abnormalities in urinalysis results (obtained
≤14 days prior to randomization).

10. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required
to assess KPS. If discrepant, the one with the lowest assessment will be considered
true.

11. Patients should be asymptomatic for jaundice prior to Day 1. Significant or
symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should
be stable and should not require modifications in analgesic management prior to Day
1.

12. Patient has been informed about the nature of the study, and has agreed to
participate in the study, and signed the Informed Consent Form (ICF) prior to
participation in any study-related activities.

Exclusion Criteria

A patient will not be eligible for inclusion in this study if any of the following
criteria apply:

1. Patient has known brain metastases, unless previously treated and well-controlled for
at least 3 months (defined as clinically stable, no edema, no steroids and stable in
2 scans at least 4 weeks apart).

2. Patient has only locally advanced disease.

3. Patient has experienced a ≥10% decrease in KPS between Baseline visit and within 72
hours prior to randomization.

4. Patient has a ≥20% decrease in serum albumin level between Baseline visit and within
72 hours prior to randomization.

5. History of malignancy in the last 5 years. Patients with prior history of in situ
cancer or basal or squamous cell skin cancer are eligible. Patients with other
malignancies are eligible if they were cured by surgery alone or surgery plus
radiotherapy and have been continuously disease-free for at least 5 years.

6. Patient uses Coumadin.

7. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
systemic therapy.

8. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis
C.

9. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery
done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks
prior to Day 1 of treatment in this study.

10. Patient has a history of allergy or hypersensitivity to any of the study drugs or any
of their excipients, or the patient exhibits any of the events outlined in the
Contraindications or Special Warnings and Precautions sections of the product or
comparator SmPC or Prescribing Information.

11. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).

12. Patients with a history of interstitial lung disease.

13. History of chronic leukemias (e.g., chronic lymphocytic leukemia).

14. Patients with high cardiovascular risk, including, but not limited to, recent
coronary stenting or myocardial infarction in the past year.

15. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

16. Patient has serious medical risk factors involving any of the major organ systems, or
serious psychiatric disorders, which could compromise the patient's safety or the
study data integrity.

17. Patient is enrolled in any other clinical protocol or investigational trial.

18. Patient is unwilling or unable to comply with study procedures, or is planning to
take vacation for 7 or more consecutive days during the course of the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to evaluate the efficacy of the combination of ABI-007 and Gemcitabine versus Gemcitabine alone in improving overall survival in patients with metastatic adenocarcinoma of the pancreas.

Outcome Time Frame:

EOS and Follow-Up

Safety Issue:

Yes

Principal Investigator

Daniel Von Hoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scottsdale Clinical Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

CA046

NCT ID:

NCT00844649

Start Date:

March 2009

Completion Date:

October 2014

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Colorado Cancer CenterDenver, Colorado  80262
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Medical College of WisconsinMilwaukee, Wisconsin  53226
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Florida Hospital Cancer InstituteOrlando, Florida  32804
Rocky Mountain Cancer CenterDenver, Colorado  80218
Ocala Oncology CenterOcala, Florida  34474
Georgia Cancer SpecialistsDecatur, Georgia  30033
Central Maine Medical CenterLewiston, Maine  04240
Pacific Shores Medical GroupLong Beach, California  90813
City of HopeDuarte, California  91010
Atlanta Cancer CareAtlanta, Georgia  30342
Genesis Cancer CenterHot Springs, Arkansas  71913
Saint Louis UniversitySt. Louis, Missouri  63104
South Carolina Oncology AssociatesColumbia, South Carolina  29201
SUNY Upstate Medical UniversitySyracuse, New York  13210
Tower Cancer Research FoundationBeverly Hills, California  90211
Lakeland Regional Cancer CenterLakeland, Florida  33805
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Lahey ClinicBurlington, Massachusetts  01805
Northeast Georgia Cancer Care, LLCAthens, Georgia  30607
UCLALos Angeles, California  90095
University of New MexicoAlbuquerque, New Mexico  87131
Virginia Cancer InstituteRichmond, Virginia  23230
Illinois Cancer CarePeoria, Illinois  61615
Texas Oncology, PADallas, Texas  75246-2006
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Virginia Commonwealth UniversityRichmond, Virginia  
Center for Cancer & Blood DisordersBethesda, Maryland  20817
Desert Hematology Oncology Medical Group, Inc.Rancho Mirage, California  92270
Kettering Medical CenterKettering, Ohio  45429
Arizona Cancer Center, University of ArizonaTucson, Arizona  85724-5081
Maine Center for Cancer MedicineScarborough, Maine  04074
University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Hematology Oncology ClinicBaton Rouge, Louisiana  70808
Swedish Health ServicesSeattle, Washington  98104
Hutchinson Clinic, PAHutchinson, Kansas  67502
Tennessee OncologyNashville, Tennessee  37203
Oncology Hematology CareCincinnati, Ohio  45242
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Phoebe Putney Cancer CenterAlbany, Georgia  31701
Piedmont Hematology OncologyWinston-Salem, North Carolina  27103
Arena Oncology Associates, PCGreat Neck, New York  11021
Mercy Physicians of OklahomaTulsa, Oklahoma  74136
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Evergreen Hematology & OncologySpokane, Washington  99218
University of Pittsburg Medical CenterPittsburg, Pennsylvania  15213
Piedmont Hospital Research InstituteAtlanta, Georgia  30309
Orchard ResearchSkokie, Illinois  60076
NorthShore University HealthSystemEvanston, Illinois  
New York Oncology Hematology PCAlbany, New York  12206
Lake County Oncology and HematologyThe Villages, Florida  32159
The University Of Texas Medical School At HoustonHouston, Texas  77030
UAB Comprenhensive Cancer Center at University of AlabamaBirmingham, Alabama  35294
Clearview Cancer Institute Oncology Specialities, P.C.Huntsville, Alabama  35805
Mayo Clinic-ScottsdaleScottsdale, Arizona  85259
Northern Arizona Hematology and Oncology Associates-AOASedona, Arizona  86336
University Cancer Institute, LLCBoynton Beach, Florida  33426
Collaborative Research GroupBoynton Beach, Florida  33435
FL Cancer SpecialistFt Myers, Florida  33916
Cancer Care & Hemaotology Specialists of ChicagolandArlington Heights, Illinois  60005
Owsley Brown Frazier Cancer CenterLouisville, Kentucky  40245
Mercy Hospital Portland, MEPortland, Maine  04102
Sidney Kimmel Comphrensive Cancer Center, John Hopkins UniversityBaltimore, Maryland  21231
Cancer Center of Excellence/University of MA Medical SchoolWorcester, Massachusetts  01655
St. Mary's/ Duluth ClinicDuluth, Minnesota  55805
University of Minnesota, Masonic Cancer CenterMinneapolis, Minnesota  55455
St. John's Medical Research InstituteSpringfield, Missouri  65807
Hem Onc Associates-NMAlbuquerque, New Mexico  87106
Mid Ohio Oncology/Hematology IncColumbus, Ohio  43219
Cancer Centers of SW OKLawton, Oklahoma  73505
Cancer Care Associates- TulsaTulsa, Oklahoma  74104
St. Mary Medical Center Hem-Onc Group, PCLanghorne, Pennsylvania  19047
Medical City Dallas-US OncologyDallas, Texas  75230-2510
Texas Oncology, PA/ Methodist Charlton Cancer CenterDallas, Texas  75237
Texas Oncology LaboratoriesFort Worth, Texas  76104
Texas Oncology- Plano EastPlano, Texas  75075
Texas Oncology-Round RockRound Rock, Texas  78681
South Texas Oncology and Hematology, P.ASan Antonio, Texas  78229
Fairfax-Northern Virginia Hematology-Oncology, P.C.Fairfax, Virginia  22031
Virginia Cancer Specialist, PCFairfax, Virginia  22031