Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery
Recruitment status was Recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Biological: cetuximab Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study |
- Complete histologic response [ Designated as safety issue: No ]
- Tolerance to neoadjuvant therapy [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Progression-free and overall survival [ Designated as safety issue: No ]
- Complete resection with negative margins (R0) [ Designated as safety issue: No ]
- Mortality [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2007 |
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of fluorouracil and cisplatin when administered with cetuximab concurrently with esophageal radiotherapy. (Phase I)
- To determine the complete histological response rate (after surgical resection). (Phase II)
Secondary
- To determine progression-free survival and overall survival. (Phase II)
- To determine the rate of resection with negative margins (R0). (Phase II)
- To determine the overall tolerance to neoadjuvant therapy. (Phase II)
- To determine the postoperative morbidity and mortality. (Phase II)
OUTLINE: This is a multicenter study. This is a dose-escalation study of cisplatin and fluorouracil.
Patients receive cetuximab IV over 2 hours on day -7, then IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also receive cisplatin IV over 1 hour on day 1 or 2 and fluorouracil IV continuously on days 1-4, 8-11, 15-18, 22-25, and 29-32. Patients undergo radiotherapy 5 days a week for 5 weeks, beginning on day 1 of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery within 6-8 weeks after completion of chemoradiotherapy.
After completion of study therapy, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 2 years.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
-
Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus
- Invasive disease
- Only Siewert type I gastroesophageal carcinoma allowed
-
Resectable disease
- T1N+, T2N0, T2N+, T3N0, or T3N+ (stage II or III)
- No visceral metastases or mediastinal extensions compromising resectability
Exclusion criteria:
- Inoperable disease
- Invasion of the tracheo-bronchial tree
- Recurring esophageal paralysis
- Esopho-tracheal fistula
- Cervical esophageal carcinoma (< 19 cm above the dental arches)
- Multifocal esophageal carcinoma
- Superficial esophageal carcinoma (T1N0)
- Esophageal carcinoma in the lymph nodes that cannot be included in the radiotherapy field or cannot be completely surgically resected
- Proven metastatic disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
- WHO performance status 0-1
- Weight loss < 15%
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Creatinine ≤ 1.25 times upper limit of normal
- PTT ≥ 80%
- Albumin ≥ 35 g/L
- FEV1 > 1 L
- Not pregnant or nursing
- Fertile patients of must use effective contraception
Exclusion criteria:
- Known liver cirrhosis
- Renal insufficiency
- Respiratory insufficiency (i.e., severe dyspnea at rest or oxygen dependence)
- Progressive coronary insufficiency
- Myocardial infarction in the past 6 months
- Legally incapacitated
- Impossible to receive study therapy due to geographical, social, or psychological reasons
- Noncompliant within constraints of the study
- Hematologic malignancy or other cancer except carcinoma in situ of the uterine cervix, treated nonmelanoma skin cancer, or intramucous disease treated within the past 3 years
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
- Prior anticancer chemotherapy or radiotherapy
- Treatment with endoprosthesis
- Surgery (esophagectomy) planned without thoracotomy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00544362
| France | |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Recruiting |
| Besancon, France, 25030 | |
| Contact: Thanh Van N'Guyen 33-81-668-240 | |
| Hopital Saint Andre | Recruiting |
| Bordeaux, France, 33075 | |
| Contact: Veronique Vendrely 33-5-5679-5808 | |
| C.H.U. de Brest | Recruiting |
| Brest, France, 29200 | |
| Contact: Jean-Philippe Metges, MD 33-2-9822-3333 | |
| CHR Clermont Ferrand, Hotel Dieu | Recruiting |
| Clermont-Ferrand, France, 63058 | |
| Contact: Denis Pezet, MD 33-73-750-494 dpezet@chu-clermontferrand.fr | |
| Federation Francophone de Cancerologie Digestive | Recruiting |
| Dijon, France, 21079 | |
| Contact: Martina Schneider 33-3-8039-3483 | |
| Hopital Du Bocage | Recruiting |
| Dijon, France, 21034 | |
| Contact: Jean-Louis Jouve 33-3-8029-3750 jean-louis.jouve@chu-dijon.fr | |
| Centre Hospital Universitaire Hop Huriez | Recruiting |
| Lille, France, 59037 | |
| Contact: Christophe Mariette, MD, PhD 33-32-44-4407 c-mariette@chru-lille.fr | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Contact: Antoine Adenis, MD, PhD 33-320-29-59-42 a-adenis@o-lambret.fr | |
| CHU de la Timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Jean-Francois Seitz, MD 33-4-9138-6023 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Marc Ychou, MD, PhD 33-4-6761-3066 mychou@valdorel.fnclcc.fr | |
| Centre Hospitalier Lyon Sud | Recruiting |
| Pierre Benite, France, 69495 | |
| Contact: Francoise Mornex, MD, PhD 33-478-864-253 francoise.mornex@chu-lyon.fr | |
| Centre Hospitalier Regional de Purpan | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Nicolas Carrere, MD, PhD 33-56-177-7610 carrere.n@chu-toulouse.fr | |
| Centre Alexis Vautrin | Recruiting |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Contact: Thierry Conroy, MD 33-3-8359-8460 | |
| Study Chair: | Martina Schneider | Federation Francophone de Cancerologie Digestive |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00544362 History of Changes |
| Other Study ID Numbers: | CDR0000564075, FFCD-0505, EU-20756, EUDRACT-2006-004770-27, MERCK-FFCD-0505 |
| Study First Received: | October 13, 2007 |
| Last Updated: | December 3, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage IIIA esophageal cancer |
stage IIIB esophageal cancer stage IIIC esophageal cancer stage IV esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Cetuximab |
Fluorouracil Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015