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

Phase 2
18 Years
70 Years
Not Enrolling
Metastatic Pancreatic Cancer

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

10 weeks

Safety Issue:


Principal Investigator

Robert L Fine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

June 2003

Completion Date:

December 2007

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Stage IVB
  • Pancreatic Neoplasms



Columbia University Medical Center New York, New York  10032