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Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer Clinical research trials and Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer. Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer clinical trial. Human subjects often get the best healthcare possible for their Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
For Condition: recurrent esophageal cancer,stage 4 esophageal cancer
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line therapy in treating patients who have metastaticesophageal cancer.
Details: OBJECTIVES: Primary - Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy. Secondary - Determine the clinical benefit in patients treated with this regimen. - Determine the tolerability of this regimen in these patients. - Determine local relapse-free survival of patients treated with this regimen. - Determine the overall survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed esophageal cancer - Metastatic disease - At least 1 unidimensionally measurable metastatic lesion - At least 10 mm by spiral scanner OR 20 mm by sequential scanner - Outside the field of prior radiotherapy - No known symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 Hepatic - Bilirubin 1.5 times normal - Alkaline phosphatase 3 times normal (5 times normal if liver metastases are present) - SGOT and SGPT 3 times normal Renal - Creatinine 1.5 mg/dL Cardiovascular - No myocardial infarction within the past 6 months - No uncontrolled angina Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No other illness or medical condition that would preclude study participation - No psychological, social, familial, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 6 months since prior fluorouracil and/or cisplatin - No other prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 6 weeks since prior radiotherapy Surgery - More than 4 weeks since prior surgery Other - No concurrent participation in another clinical study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PascalArtru, , Clinique Saint Jean
Hopital Saint Antoine *Recruiting*
Paris, , 75571
France
Recruiting Aimery Gramont 33-1-49-282-336
Hopital Saint Andre *Recruiting*
Bordeaux, , 33075
France
Recruiting Denis Smith 33-5-5679-5679
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Thierry Andre 33-1-6177-0708
Centre Hospital Universitaire Hop Huriez *Recruiting*
Lille, , 59037
France
Recruiting Stephane Cattan 33-3-2044-5962
Clinique Ste - Marie *Recruiting*
Pontoise, , 95300
France
Recruiting Marie-Helene Filippi 33-01-3038-5805
Centre Medico-Chirurgical Foch *Recruiting*
Suresnes, , 92151
France
Recruiting May Mabro 33-1-4625-2168
Hopital Notre-Dame de Bon Secours *Recruiting*
Metz, , 57038
France
Recruiting Sabine Walter 33-387-553-554
Hopital Bichat - Claude Bernard *Recruiting*
Paris, , 75018
France
Recruiting Cedric Lecaille 33-1-4025-7000
Hopital Drevon *Recruiting*
Dijon, , 21000
France
Recruiting Michel Flesch 33-380-364-822
Clinique Saint Jean *Recruiting*
Lyon, , 69008
France
Recruiting Gerard Gledo 33-4-7878-1010
Clinique La Casamance *Recruiting*
Abugne, , 13400
France
Recruiting Philippe Dalivoust 33-4-9188-4285
Hopital Haut Leveque *Recruiting*
Pessac, , 33604
France
Recruiting Jean-Louis Legoux 335-5765-6438
Centre Jean Bernard *Recruiting*
Le Mans, , 72000
France
Recruiting Gerard Ganem 334-339-1300
Clinique Armoricaine De Radiologie *Recruiting*
Saint Brieux, , F-22015
France
Recruiting Pierre-Luc Etienne 33-2-9675-2222
Clinique Francois *Recruiting*
Saint-Dizier, , 52100
France
Recruiting Philippe Colin 33-3-2556-7777
Additional Information:
Study ID Numbers: CDR0000349275; FRE-GERCOR-D00-2,EU-20328
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075738
Other Stage 4 Esophageal Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
2. Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
3. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
4. Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
5. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
Related Studies:
Other stage 4 esophageal cancer Clinical Trials
Other Clinical Trials
Other Saint Brieux Clinical Trials
Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
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