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

NCT01360086 | Completed Phase 2

• 5 other identifiers: CDR0000699219FFCD-0901EU-21111EUDRACT-2010-023115-33MERCK-FFCD-0901
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Objective response rate according to RECIST V1.1 criteria

  3 months

• Non-toxicity rate

  3 months

Secondary Outcomes (7)

• Tolerance

  From Inclusion

• Post-operative mortality and morbidity

  After Surgery

• Rate of recurrence at 1 and 2 years

  1 year and 2 years

• Recurrence-free survival at 3 years

  3 years

• Disease-free survival at 3 years

  3 years

Study Arms (1)

Perioperative CT with 5FU-Cisplatine-Cetuximab

EXPERIMENTAL

6 cycles of intravenous Cetuximab (500mg/m²), Cisplatine (50mg/m²) and LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks. Surgery was planned 3-4 weeks after the end of neaodjuvant CT and postoperative CT, with the same regimen, planned for 6-8 weeks after surgery.

Biological: cetuximab; Drug: cisplatin; Drug: fluorouracil; Drug: leucovorin calcium; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery

Interventions

cetuximab BIOLOGICAL

6 cycles of intravenous Cetuximab (500mg/m²),

Perioperative CT with 5FU-Cisplatine-Cetuximab

cisplatin DRUG

Cisplatine (50mg/m²)

Perioperative CT with 5FU-Cisplatine-Cetuximab

fluorouracil DRUG

LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks

Perioperative CT with 5FU-Cisplatine-Cetuximab

leucovorin calcium DRUG

Perioperative CT with 5FU-Cisplatine-Cetuximab

adjuvant therapy PROCEDURE

Perioperative CT with 5FU-Cisplatine-Cetuximab

neoadjuvant therapy PROCEDURE

Perioperative CT with 5FU-Cisplatine-Cetuximab

quality-of-life assessment PROCEDURE

Perioperative CT with 5FU-Cisplatine-Cetuximab

therapeutic conventional surgery PROCEDURE

Surgery was planned 3-4 weeks after the end of neaodjuvant CT

Perioperative CT with 5FU-Cisplatine-Cetuximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (2)

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

CHU - Robert Debre

Reims, 51092, France

Location

Related Publications (2)

• Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.

  PMID: 24982463 RESULT

• Gronnier C, Mariette C, Lepage C, Monterymard C, Jary M, Ferru A, Baconnier M, Adhoute X, Tavan D, Perrier H, Guerin-Meyer V, Lecaille C, Bonichon-Lamichhane N, Pillon D, Cojocarasu O, Egreteau J, D'journo XB, Dahan L, Locher C, Texereau P, Collet D, Michel P, Ben Abdelghani M, Guimbaud R, Muller M, Bouche O, Piessen G. Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study. Cancers (Basel). 2023 Apr 6;15(7):2188. doi: 10.3390/cancers15072188.

  PMID: 37046849 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cetuximab; Cisplatin; Fluorouracil; Leucovorin; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Christophe Mariette, MD, PhD

  Centre Hospitalier Regional et Universitaire de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 25, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 30, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)