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OpenTrials
Completed

NCT Number: NCT00004003

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

About this study

OBJECTIVES: I. Determine the overall survival in patients with unresectable stage III or IV pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. II. Determine the resectability rate with curative intent in patients with unresectable stage III pancreatic adenocarcinoma treated with this regimen. III. Assess the tolerability and toxicity of this treatment regimen in this patient population. IV. Evaluate this regimen in terms of response rate, response duration, and overall time to disease progression in these patients. V. Evaluate the quality of life in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, followed by cisplatin IV over 30 minutes on days 1 and 15. Patients receive fluorouracil as a continuous infusion on days 1-15. Courses repeat every 28 days. Quality of life is assessed every 28 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Unresectable locally advanced (stage III) OR Metastatic (stage IV) Gallbladder or biliary tract cancer allowed No endocrine tumors or lymphoma of the pancreas No CNS metastases

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 3.0 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection No other serious systemic disorders No other active malignancies within the past year except curatively treated basal cell skin cancer or carcinoma in situ of the cervix Must have central venous access device (i.e., Infusaport or PASPORT) Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for locally advanced or metastatic disease At least 6 months since prior adjuvant chemotherapy No prior gemcitabine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Treatment and study plan

Cisplatin

Drug

Fluorouracil

Drug

gemcitabine hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Study of Gemcitabine, Cisplatin, and 5-Fluorouracil in the Treatment of Advanced Pancreatic Cancer

Important dates

Study start
1999
Primary completion
2001
Study completion
2003
First posted
Feb 12, 2004
Registry last updated
Apr 5, 2013

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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