Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
NCT ID: NCT00003810
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-08-11
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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docetaxel
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Principal Investigators
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Robert C. Shepard, MD
Role: STUDY_CHAIR
University of Virginia
Locations
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Indiana University Cancer Center
Indianapolis, Indiana, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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Shepard RC, Levy D, Stuart K, et al.: Pancreatic cancer: biweekly gemcitabine/docetaxel chemotherapy. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-614, 2001.
Shepard RC, Levy DE, Berlin JD, Stuart K, Harris JE, Aviles V, Thomas JP, Benson AB 3rd. Phase II study of gemcitabine in combination with docetaxel in patients with advanced pancreatic carcinoma (E1298). A trial of the eastern cooperative oncology group. Oncology. 2004;66(4):303-9. doi: 10.1159/000078331.
Ryan DP, Kulke MH, Fuchs CS, Grossbard ML, Grossman SR, Morgan JA, Earle CC, Shivdasani R, Kim H, Mayer RJ, Clark JW. A Phase II study of gemcitabine and docetaxel in patients with metastatic pancreatic carcinoma. Cancer. 2002 Jan 1;94(1):97-103. doi: 10.1002/cncr.10202.
Other Identifiers
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ECOG-1298
Identifier Type: -
Identifier Source: secondary_id
CDR0000066955
Identifier Type: -
Identifier Source: org_study_id
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