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Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)

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ClinicalTrials.gov Identifier: NCT00996333
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : June 22, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is designed to determine whether an investigational drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Gemcitabine, Docetaxel, Capecitabine Phase 2

Detailed Description:
This Phase II multicenter study is designed to determine the response rate to a biochemically synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic pancreatic cancer. It will further determine the overall and one year survival rates, the diseasefree interval, and the toxicities for this regimen in patients with metastatic pancreatic cancer.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)
Study Start Date : June 2003
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Gemzar, Taxotere, Xeloda

Gemcitabine, Docetaxel, Capecitabine:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

Drug: Gemcitabine, Docetaxel, Capecitabine

1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11

This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.

Other Names:
  • Gemzar
  • Xeloda
  • Taxotere


Outcome Measures

Primary Outcome Measures :
  1. To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer [ Time Frame: 10 weeks ]
    Data was not analyzed because original PI left institution before data analysis was completed.


Secondary Outcome Measures :
  1. Determine Overall and One Year Survival Rates [ Time Frame: One year ]
    Data was not analyzed because original PI left institution before data analysis was completed.

  2. Toxicity Assessment [ Time Frame: Every month ]
    Data was not analyzed because original PI left institution before data analysis was completed.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of pancreas metastatic to liver and/or lungs or peritoneal surface. (a.k.a. Stage IV B).
  • No prior chemotherapy with Gemzar, Xeloda and Taxotere.
  • Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.
  • The following lesions conventionally are not considered measurable:

    • CNS lesions
    • Blastic or lytic bone lesions (which should be documented and followed)
    • Radiated lesions unless progression after RT is documented
  • Ineligible for other high priority national or institutional studies
  • Prior radiation and surgery allowed:

    • > 3 weeks since surgery
    • > 4 weeks since RT
  • Non pregnant females who are not breast feeding with a negative serum or urine β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
  • Clinical Parameters:

    • Life expectancy > 2 months
    • Age 18 - 70 years old
    • Performance status 0-2 (ECOG)
    • Peripheral Neuropathy must be < grade 1
    • Able to tolerate oral medications
  • Required initial laboratory data:

    • Absolute Neutrophil Count > 1,500 μl
    • White Blood Count > 3,000/μl
    • Platelet count > 100,000/μl
    • BUN < 1.5 x normal
    • Creatinine < 1.5 normal
    • Hemoglobin > 8.0 g/dl
    • Serum Albumin > 3 mg/dl
    • Total Bilirubin < 2.0 mg/dl
    • SGOT, SGPT, Alkaline Phosphatase SGOT and SGPT may be up to 3.0 x ULN if Alk Phos < 2.0 x ULN; or Alk Phos may be up to 3.0 x ULN if SGOT and SGPT are < 2.0 x ULN

Exclusion Criteria:

  • Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
  • Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
  • The patient has not had a prior malignancy in last 5 years other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer
  • No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
  • Patients with brain metastases are excluded.
  • Patients known to have HIV will be excluded.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996333


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Sanofi
Investigators
Principal Investigator: Robert L Fine, MD Columbia University
More Information

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00996333     History of Changes
Other Study ID Numbers: AAAB8628
First Posted: October 16, 2009    Key Record Dates
Results First Posted: June 22, 2016
Last Update Posted: July 25, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Columbia University:
Stage IVB

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators