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| Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004003 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Study of Gemcitabine, Cisplatin, and 5-Fluorouracil in the Treatment of Advanced Pancreatic Cancer |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Study Chair: | Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute |
More Information
| Study ID Numbers: | CDR0000067213, WSU-D-1993, WSU-04-03-99-M01-FB, NCI-G99-1553 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004003 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III pancreatic cancer recurrent pancreatic cancer stage IV pancreatic cancer |
|
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Antiviral Agents Immunosuppressive Agents Recurrence Digestive System Diseases |
Cisplatin Radiation-Sensitizing Agents Fluorouracil Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Cisplatin Fluorouracil Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |
