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

Primary Purpose

Metastatic Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine, Docetaxel, Capecitabine
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Stage IVB

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemzar, Taxotere, Xeloda

Arm Description

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

Outcomes

Primary Outcome Measures

To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer
Data was not analyzed because original PI left institution before data analysis was completed.

Secondary Outcome Measures

Determine Overall and One Year Survival Rates
Data was not analyzed because original PI left institution before data analysis was completed.
Toxicity Assessment
Data was not analyzed because original PI left institution before data analysis was completed.

Full Information

First Posted
October 14, 2009
Last Updated
June 22, 2016
Sponsor
Columbia University
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00996333
Brief Title
Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Official Title
Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
Stage IVB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemzar, Taxotere, Xeloda
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Docetaxel, Capecitabine
Other Intervention Name(s)
Gemzar, Xeloda, Taxotere
Intervention Description
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.
Primary Outcome Measure Information:
Title
To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer
Description
Data was not analyzed because original PI left institution before data analysis was completed.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Determine Overall and One Year Survival Rates
Description
Data was not analyzed because original PI left institution before data analysis was completed.
Time Frame
One year
Title
Toxicity Assessment
Description
Data was not analyzed because original PI left institution before data analysis was completed.
Time Frame
Every month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Fine, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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