Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) for Pancreatic Adenocarcinoma

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01161186
First received: July 9, 2010
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to evaluate optimal dose and safety of the combination of Abraxane, gemcitabine, and Xeloda (capecitabine) (AGX) as first-line therapy in patients with metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Neoplasms
Pancreatic Cancer
Adenocarcinoma
Drug: nab-paclitaxel, gemcitabine, capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) (AGX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • to establish the maximal tolerated dose (MTD) of the AGX combination in patients with previously untreated, metastatic pancreatic adenocarcinoma. [ Time Frame: Ongoing evaluation through sequential dose cohorts ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the safety profile of this combination (AGX) using NCI-CTCAE v.4 criteria. [ Time Frame: Ongoing evaluation for all patients throughout the course of treatment ] [ Designated as safety issue: Yes ]
  • To obtain a preliminary assessment of the clinical efficacy of AGX as measured by time to tumor progression, overall survival, objective radiographic response (ORR), and CA 19-9 biomarker response [ Time Frame: Efficacy evaluations at 2-month intervals; patients followed for survival throughout lifetime. ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nab-paclitaxel,Gemcitabine, and Capecitabine Drug: nab-paclitaxel, gemcitabine, capecitabine
{nab-paclitaxel: Intravenous, 100 to 150 mg/m2 over 30 minutes once per cycle.} {gemcitabine: Intravenous, 750 to 1000 mg/m2 at 10mg/m2/minute once per cycle.} {capecitabine: oral, 500 to 1000 mg/m2 b.i.d. 7 days per cycle}
Other Names:
  • Abraxane
  • nanoparticle albumin bound paclitaxel
  • Xeloda
  • Gemzar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed pancreatic adenocarcinoma
  2. Stage IV disease (metastatic only)
  3. No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
  4. ECOG performance score of 0-1
  5. At least 18 years of age
  6. Evidence of either or both of the following:

    • RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
    • An elevated serum CA19-9 at baseline ( ≥ 2X ULN)
  7. Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
  8. Adequate bone marrow function:

    • ANC ≥ 1500/uL
    • platelet count ≥ 100,000/uL
    • hemoglobin ≥ 9.0 g/dL
    • Total bilirubin ≤ 1.5 X ULN
    • AST (SGOT) ≤ 2.5 X ULN
    • ALT (SGPT) ≤ 2.5 X ULN

10. Adequate renal function as determined by either:

  • Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used). The Modified Cockcroft-Gault formula is as follows:

((140 - age(yrs)) x (actual weight(kg))) / (72 x serum creatinine(mg/dl))

  • Multiply by another factor of 0.85 if female
  • Serum creatinine ≤ 1.5 X ULN 11. Ability to swallow oral medications 12. Ability to understand the nature of this study protocol and give written informed consent 13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed > 6 months prior to the time of study enrollment.
  2. Inability to comply with study and/or follow-up procedures.
  3. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
  4. Presence of central nervous system or brain metastases.
  5. Life expectancy < 12 weeks
  6. Pregnancy (positive pregnancy test) or lactation.
  7. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
  8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
  9. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
  10. Known, existing uncontrolled coagulopathy.
  11. Pre-existing sensory neuropathy > grade 1.
  12. Major surgery within 4 weeks of the start of study treatment, without complete recovery.
  13. Concurrent/pre-existing use of coumadin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161186

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84115
Sponsors and Collaborators
University of California, San Francisco
Celgene Corporation
Investigators
Principal Investigator: Andrew Ko, M.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01161186     History of Changes
Other Study ID Numbers: CC#10451
Study First Received: July 9, 2010
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
pancreas
cancer
abraxane
metastatic
gemcitabine
capecitabine
adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Capecitabine
Gemcitabine
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents

ClinicalTrials.gov processed this record on September 30, 2014