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A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma


OBJECTIVES: I. Determine the objective response rate of patients with pancreatic
adenocarcinoma treated with combination gemcitabine and docetaxel. II. Determine the
toxicity profile of this combination therapy in these patients. III. Assess the survival
rate of these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30
minutes. Patients receive treatment every other week for 8 weeks (4 courses). Patients may
continue treatment in the absence of unacceptable toxicity or disease progression. Patients
are followed every 12 weeks until death.

PROJECTED ACCRUAL: This study will accrue approximately 10 patients per month for a maximum
of 33 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or poorly differentiated
carcinoma of the pancreas Metastatic disease with at least 1 bidimensionally measurable
lesion OR Locally advanced disease that is either recurrent or not amenable to surgery
Measurable disease outside of prior radiation port or disease progression within the port

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at
least 125,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no
greater than 2.5 times ULN (less than 3 times ULN if liver metastases) Renal: Creatinine
no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for metastatic disease At least 1 year since prior adjuvant chemotherapy
Prior chemoradiotherapy as initial therapy allowed Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks since prior
radiotherapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert C. Shepard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000066955

NCT ID:

NCT00003810

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212