|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003029 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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. |
| Estimated Enrollment: | 200 |
| Study Start Date: | May 1997 |
OBJECTIVES:
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Belgium | |
| Hopital de Jolimont | |
| Haine Saint Paul, Belgium, 7100 | |
| Les Cliniques Saint-Joseph ASBL | |
| Liege, Belgium, B 4000 | |
| France | |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Centre Hospitalier de Montlucon | |
| Montlucon, France, 03109 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Centre Hospitalier de la Cote Basque | |
| Bayonne, France, 64109 | |
| Clinique Hartmann | |
| Neuilly sur Seine, France, 92200 | |
| Hopital Bellevue | |
| Saint Etienne, France, 42055 | |
| Hopital Cochin | |
| Paris, France, 75674 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 55038 | |
| Hopital Paul Brousse | |
| Villejuif, France, 94804 | |
| Hopital Perpetuel Secours | |
| Levallois-Perret, France, 92300 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| 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 | |
| Investigator: | Francis Levi, MD, PhD | Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse |
More Information
| Study ID Numbers: | CDR0000065623, EORTC-05962 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003029 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Cisplatin Fluorouracil Therapeutic Uses Pancreatic Diseases Endocrine Gland Neoplasms |