Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075738
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007
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Purpose
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. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Cisplatin
Levoleucovorin
Irinotecan
Irinotecan hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective response rate [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical benefit [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Local relapse-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Study Start Date: | October 2003 |
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075738
Locations
| France | |
| Clinique La Casamance | |
| Abugne, France, 13400 | |
| Hopital Saint Andre | |
| Bordeaux, France, 33075 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Centre Hospital Universitaire Hop Huriez | |
| Lille, France, 59037 | |
| Clinique Saint Jean | |
| Lyon, France, 69008 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 57038 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital Haut Leveque | |
| Pessac, France, 33604 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95300 | |
| Clinique Armoricaine De Radiologie | |
| Saint Brieuc, France, F-22015 | |
| Clinique Francois | |
| Saint-Dizier, France, 52100 | |
| Centre Medico-Chirurgical Foch | |
| Suresnes, France, 92151 | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Investigator: | Pascal Artru, MD | Clinique Saint Jean |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00075738 History of Changes |
| Other Study ID Numbers: | CDR0000349275, FRE-GERCOR-D00-2, EU-20328 |
| Study First Received: | January 9, 2004 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV esophageal cancer recurrent esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Irinotecan Cisplatin Fluorouracil Camptothecin 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 |
ClinicalTrials.gov processed this record on May 19, 2013