Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
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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 and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: cisplatin Drug: fluorouracil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial. |
| Enrollment: | 200 |
| Study Start Date: | May 1997 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer.
- Test the value of adding cisplatin to fluorouracil in extending survival in these patients.
OUTLINE: This is a multicenter, randomized study.
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment.
Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant.
Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs.
PROJECTED ACCRUAL: 200 patients will be accrued.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor
- Locally advanced and/or metastatic pancreatic cancer
- No measurable or evaluable target lesion is required
- No brain metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 40%-100%
Hematopoietic:
- WBC at least 3,000/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 3 times normal
Renal:
- Creatinine no greater than 1.24 mg/dL OR
- Creatinine clearance at least 80 mL/min
Cardiovascular:
- No overt cardiac disease
Other:
- No peripheral neuropathy
- No uncontrolled infectious or chronic disease
- No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunologic therapy
Chemotherapy:
- No prior chemotherapy allowed
Endocrine therapy:
- No concurrent hormonal therapy
- At least 2 weeks since corticoid treatment
Radiotherapy:
- No prior radiotherapy allowed except as an analgesic treatment on metastasis
Surgery:
- Not specified
Contacts and Locations| Belgium | |
| Hopital de Jolimont | |
| Haine Saint Paul, Belgium, 7100 | |
| Les Cliniques Saint-Joseph ASBL | |
| Liege, Belgium, B 4000 | |
| France | |
| Centre Hospitalier de la Cote Basque | |
| Bayonne, France, 64109 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Hopital Perpetuel Secours | |
| Levallois-Perret, France, 92300 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 55038 | |
| Centre Hospitalier de Montlucon | |
| Montlucon, France, 03109 | |
| Clinique Hartmann | |
| Neuilly sur Seine, France, 92200 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Hopital Cochin | |
| Paris, France, 75674 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Hopital Bellevue | |
| Saint Etienne, France, 42055 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Hopital Paul Brousse | |
| Villejuif, France, 94804 | |
| Israel | |
| Wolfson Medical Center | |
| Holon, Israel, 58100 | |
| Italy | |
| Universita G.D'Annunzio Di Chieti | |
| Chieti, Italy, 66100 | |
| Portugal | |
| Hospital Fernando Fonseca | |
| Amadora, Portugal, P-2700 | |
| Study Chair: | Francis Levi, MD, PhD | Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00003029 History of Changes |
| Other Study ID Numbers: | EORTC-05962, EORTC-05962 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013