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

Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Pancreatic Cancer

Intervention: Gemcitabine, Docetaxel, Capecitabine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Robert L Fine, MD, Principal Investigator, Affiliation: Columbia University

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine response rate to the GTX regimen in patients with pancreatic cancer

Secondary outcome:

Determine overall and one year survival rates

Toxicity assessment

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Columbia University Medical Center, New York, New York 10032, United States
Additional Information

Starting date: June 2003
Last updated: February 12, 2013

Page last updated: August 23, 2015

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