Combination Chemotherapy in Treating Patients With Locally NCT00003810

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00003810
Other study ID #	CDR0000066955
Secondary ID	ECOG-1298
Status	Completed
Phase	Phase 2
First received
Last updated
Start date	August 11, 1999

Study information
Verified date	June 2023
Source	Eastern Cooperative Oncology Group
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more that one drug may kill more tumor cells. 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.

Description:

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.

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date	May 2002
Accepts healthy volunteers	No
Gender	All
Age group	18 Years to 120 Years
Eligibility	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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• docetaxel

• gemcitabine hydrochloride

Locations
Country	Name	City	State
United States	Greater Baltimore Medical Center and Cancer Center	Baltimore	Maryland
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Vanderbilt Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska

Sponsors *(2)*
Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,

References & Publications (3)

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. — View Citation

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. — View Citation

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Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas

Clinical Trial Details — Status: Completed

Administrative data

Study information