Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
This study has been completed.
Sponsor:
Fondation Francaise de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303758
First received: March 15, 2006
Last updated: October 22, 2010
Last verified: December 2006
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Purpose
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Cisplatin
Levoleucovorin
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Percentage of patients needing second-line therapy [ Designated as safety issue: No ]
- Duration of hospitalization [ Designated as safety issue: No ]
| Estimated Enrollment: | 202 |
| Study Start Date: | October 2005 |
OBJECTIVES:
Primary
- Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the percentage of these patients needing second-line therapy.
- Compare the duration of hospitalization of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.
Quality of life is assessed at baseline and then every 2 months.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 202 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 |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla
- Metastatic disease
- Unresectable disease
Measurable disease, meeting the following criteria:
- No prior radiotherapy to the only site of measurable disease
- Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods
- No brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 2 months
- No contraindication to chemotherapy
- Creatinine clearance > 60 mL/min
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Alkaline phosphatase < 5 times normal
- Bilirubin ≤ 3 mg/dL
- No coronary insufficiency
- No symptomatic cardiac disease
- Good hydration possible
- No Child-Pugh class B or C cirrhosis
- No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior palliative or adjuvant chemotherapy
- At least 4 weeks since prior radiotherapy
- No radiotherapy during or for 4 weeks after study therapy
- No other concurrent anticancer therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303758
Locations
| France | |
| Centre Hospitalier d'Abbeville | |
| Abbeville, France, 80101 | |
| Hopital Duffaut | |
| Avignon, France, 84902 | |
| Centre Hospitalier de Blois | |
| Blois, France, 41016 | |
| Centre Hospitalier Universitaire Ambroise Pare - Boulogne | |
| Boulogne, France, F-92104 | |
| Centre Hospitalier Docteur Duchenne | |
| Boulogne Sur Mer, France, 62200 | |
| C.H. Bourg En Bresse | |
| Bourg En Bresse, France, 01012 | |
| Centre Hospitalier Pierre Oudot | |
| Bourgoin-Jallieu, France, 38300 | |
| Centre Hospitalier Universitaire d'Amiens | |
| Caen, France, 14076 | |
| Centre Hospitalier de Chalons-en-Champagne | |
| Chalons-en-Champagne, France, 51000 | |
| CHR Clermont Ferrand, Hotel dieu | |
| Clermont-Ferrand, France, 63003 | |
| Hopital Beaujon | |
| Clichy, France, 92118 | |
| Hopital Louis Pasteur | |
| Colmar, France, 68024 | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Hopital Du Bocage | |
| Dijon, France, 21034 | |
| Centre Hospitalier Draguignan | |
| Draguignan, France, 83300 | |
| Centre Hospitalier De Dunkerque - CHD | |
| Dunkerque, France, 59240 | |
| Centre Hospitalier Intercommunal St. Aubin les Elbeuf | |
| Elbeuf, France, 76503 | |
| CHU de Grenoble - Hopital de la Tronche | |
| Grenoble, France, 38043 | |
| Clinique Pasteur | |
| Guilherand Granges, France, 07500 | |
| Hopital Robert Boulin | |
| Libourne, France, 33500 | |
| Centre Hospitalier Regional et Universitaire de Lille | |
| Lille, France, 59037 | |
| Centre Hospital Universitaire Hop Huriez | |
| Lille, France, 59037 | |
| Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| CHU Nord | |
| Marseille, France, 13915 | |
| Hopital Saint Joseph | |
| Marseille, France, 13008 | |
| Centre Hospitalier de Martigues | |
| Martigues, France, 13698 | |
| Centre Hospitalier General de Mont de Marsan | |
| Mont-de-Marsan, France, 40000 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| CHR Hotel Dieu | |
| Nantes, France, 44093 | |
| CHR D'Orleans - Hopital de la Source | |
| Orleans, France, 45100 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75015 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital Haut Leveque | |
| Pessac, France, 33604 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95301 | |
| CHU - Robert Debre | |
| Reims, France, 51092 | |
| Centre Eugene Marquis | |
| Rennes, France, 35064 | |
| Hopital Charles Nicolle | |
| Rouen, France, 76031 | |
| Clinique Armoricaine De Radiologie | |
| Saint Brieuc, France, F-22015 | |
| Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault | |
| Saint Martin Boulogne, France, 62280 | |
| Centre Hospitalier de Saint-Quentin | |
| Saint-Quentin, France, 02321 | |
| Centre Hospitalier de Semur en Auxois | |
| Semur en Auxois, France, 21140 | |
| Centre Hospitalier de Soissons | |
| Soissons cedex, France, 02209 | |
| Hopital Universitaire Hautepierre | |
| Strasbourg, France, 67098 | |
| Centre Hospitalier de Tarbes | |
| Tarbes, France, 65013 | |
| Nouvelle Clinique Generale | |
| Valence, France, 26000 | |
Sponsors and Collaborators
Fondation Francaise de Cancerologie Digestive
Investigators
| Study Chair: | Jean-Francois Seitz, MD | CHU de la Timone |
| Investigator: | Jean-Louis Legoux, MD | Hopital Haut Leveque |
| Investigator: | Pascal Hammel, MD, PhD | Hopital Beaujon |
More Information
Additional Information:
Publications:
Mitry E, Dahan L, Ychou M, et al.: LV5FU2-cisplatin followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: preliminary results of a randomized phase III trial (FFCD 0301). [Abstract] J Clin Oncol 26 (Suppl 15): A-4513, 2008.
| ClinicalTrials.gov Identifier: | NCT00303758 History of Changes |
| Other Study ID Numbers: | CDR0000453841, FFCD-0301, EU-20543 |
| Study First Received: | March 15, 2006 |
| Last Updated: | October 22, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the pancreas recurrent pancreatic cancer 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 Gemcitabine Cisplatin Fluorouracil Leucovorin Levoleucovorin 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 Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Antiviral Agents |
ClinicalTrials.gov processed this record on May 21, 2013