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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Robert L. Fine, Columbia University
ClinicalTrials.gov Identifier:
NCT00996333
First received: October 14, 2009
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Metastatic Pancreatic Cancer
Drug: Gemcitabine, Docetaxel, Capecitabine
Phase 2

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: Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • To determine response rate to the GTX regimen in patients with pancreatic cancer [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine overall and one year survival rates [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Toxicity assessment [ Time Frame: Every month ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: June 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemzar, Taxotere, Xeloda
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  • 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
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: 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

No publications provided

Responsible Party: Robert L. Fine, Associate Professor of Medicine at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT00996333     History of Changes
Other Study ID Numbers: AAAB8628
Study First Received: October 14, 2009
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 16, 2014