Study Of Gemzar®, Taxotere®, And Xeloda® (GTX) In Patients With Metastatic Pancreatic Cancer (Stage IVB)

Study Overview

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

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.

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.

Metastatic Pancreatic Cancer

DRUG: Gemcitabine, Docetaxel, Capecitabine

AAAB8628

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-10-14	Results First Submitted 2016-04-27	Last Update Submitted that met QC Criteria 2016-06-22
First Submitted that Met QC Criteria 2009-10-15	Results First Submitted that Met QC Criteria 2016-05-16	Last Update Posted (ESTIMATED) 2016-07-25
First Posted (ESTIMATED) 2009-10-16	Results First Posted 2016-06-22	Last Verified 2016-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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.

Participant Group/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.

Primary Outcome Measures	Measure Description	Time Frame
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.	10 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Determine Overall and One Year Survival Rates	Data was not analyzed because original PI left institution before data analysis was completed.	One year
Toxicity Assessment	Data was not analyzed because original PI left institution before data analysis was completed.	Every month

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sanofi

Investigators

PRINCIPAL_INVESTIGATOR: Robert L Fine, MD, Columbia University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record