Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01360086
First received: May 20, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, 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. Giving more than one drug (combination chemotherapy) together with cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin, and leucovorin calcium together with cetuximab and to see how well they work in treating patients with adenocarcinoma of the stomach or gastroesophageal junction.


Condition Intervention Phase
Adenocarcinoma of the Gastroesophageal Junction
Gastric Cancer
Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate according to RECIST V1.1 criteria [ Designated as safety issue: No ]
  • Non-toxicity rate [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of macroscopically and microscopically complete surgical resection (R0) [ Designated as safety issue: No ]
  • Tolerance [ Designated as safety issue: Yes ]
  • Post-operative mortality and morbidity [ Designated as safety issue: Yes ]
  • Rate of recurrence at 1 and 2 years [ Designated as safety issue: No ]
  • Recurrence-free survival at 3 years [ Designated as safety issue: No ]
  • Disease-free survival at 3 years [ Designated as safety issue: No ]
  • Overall survival at 3 years [ Designated as safety issue: No ]
  • Quality of life as assessed by QLC-C30 and STO-22 questionnaires [ Designated as safety issue: No ]
  • Correlation between the response rate and the degree of skin toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 63
Study Start Date: May 2011
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the objective response rate according to RECIST V1.1 criteria in patients with adenocarcinoma of the stomach or gastroesophageal junction treated with neoadjuvant chemotherapy comprising fluorouracil, cisplatin, leucovorin calcium, and cetuximab followed by surgery and adjuvant chemotherapy.
  • To determine the non-toxicity rate in these patients.

Secondary

  • To determine the rate of macroscopically and microscopically complete surgical resection (R0).
  • To determine the overall tolerance in patients treated with this regimen.
  • To determine post-operative mortality and morbidity in these patients.
  • To determine the rate of recurrence at 1 and 2 years in these patients.
  • To determine recurrence-free survival at 3 years in these patients.
  • To determine disease-free survival at 3 years in these patients.
  • To determine overall survival at 3 years in these patients.
  • To determine quality of life using EORTC QLC-C30 and STO-22 questionnaires.
  • To determine the correlation between the response rate and the degree of skin toxicity.

OUTLINE: This is a multicenter study.

  • Neoadjuvant therapy and surgery: Patients receive leucovorin calcium IV over 2 hours, cisplatin IV, fluorouracil IV continuously over 46 hours, and cetuximab IV over 1-2 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks after completing neoadjuvant chemotherapy, patients undergo surgery.
  • Adjuvant therapy: Within 4-8 weeks after completing neoadjuvant chemotherapy, patients receive leucovorin calcium, cisplatin, fluorouracil, and cetuximab as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires (QLC-C30 and STO-22) periodically. Blood and tissue samples are collected periodically for correlative and translational studies.

After completing study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 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 adenocarcinoma of the stomach or gastroesophageal junction

    • Stage IB, II, or III disease according to TNM classification OR type I, II, or III disease according to Siewert classification

      • TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)
    • Disease considered operable with curative intent
  • No gastric scirrhous carcinoma (linitis plastica)

    • Forms with independent cells are not considered linitis
  • Measurable disease according to RECIST V1.1
  • No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the gastroesophageal junction type I

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Polynuclear neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine clearance > 50 mL/min
  • Bilirubin < 1.5 times normal
  • Serum albumin > 30 g/L
  • Prothrombin time ≥ 80%
  • FEV1 > 1 L in case of thoracotomy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known cirrhosis
  • No other progressive condition that has not been stabilized including the following:

    • Hepatic failure
    • Renal failure
    • Respiratory failure
    • NYHA class III-IV congestive heart failure
    • Unstable angina
    • Myocardial infarction in the past 6 months
    • Significant arrhythmias in the past 12 months
  • No recent weight loss exceeding 15%
  • No interstitial pneumonia
  • No other malignant tumor within the past 5 years except for basal cell skin carcinoma or cancer in situ of the cervix
  • No psychological, familial, or geographical reasons that will preclude the patient being monitored regularly
  • No persons deprived of liberty or under guardianship (Disability Act)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy for gastric cancer
  • No other concurrent anticancer treatment, immunotherapy, or hormone therapy
  • No prior abdominal or thoracic radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360086

Locations
France
Centre Hospitalier Regional et Universitaire de Lille Recruiting
Lille, France, 59037
Contact: Contact Person    33-3-2044-4411    Christophe.mariette@chru-lille.fr   
CHU - Robert Debre Recruiting
Reims, France, 51092
Contact: Contact Person    33-3-2678-7172    obouche@chu-reims.fr   
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Christophe Mariette, MD, PhD Centre Hospitalier Regional et Universitaire de Lille
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01360086     History of Changes
Other Study ID Numbers: CDR0000699219, FFCD-0901, EU-21111, EUDRACT-2010-023115-33, MERCK-FFCD-0901
Study First Received: May 20, 2011
Last Updated: December 9, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the gastroesophageal junction
adenocarcinoma of the stomach
stage IB gastric cancer
stage IIA gastric cancer
stage IIB gastric cancer
stage IIIA gastric cancer
stage IIIB gastric cancer
stage IIIC gastric cancer

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cetuximab
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

ClinicalTrials.gov processed this record on July 28, 2014