NCT Number: NCT00003810
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
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.
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Notify MeKey information
Conditions
Age range
18 year–120 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Indiana University Cancer Center, Indianapolis, Indiana, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
gemcitabine hydrochloride
DrugSponsors and collaborators
Lead sponsor
Eastern Cooperative Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma
Important dates
- Study start
- 1999
- Primary completion
- 2002
- First posted
- Aug 4, 2004
- Registry last updated
- Jun 15, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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