Clinical trial of chemotherapy combination cisplatin + fluorouracil with the novel targeted agent afatinib in patients with inoperable gastric cancer
- Conditions
- Inoperable gastric and gastroesophageal junction cancerMedDRA version: 15.0Level: LLTClassification code 10017760Term: Gastric cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006198-25-GR
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
1. Patients with histological or cytological diagnosis of gastric and/or gastroesophageal
junction adenocarcinoma/carcinoma.
2. Locally advanced or metastatic inoperable disease.
3. Life expectancy =12 weeks.
4. Patients who may have undergone any type of palliative treatment for localised disease, including surgical approaches and palliative radiotherapy, but not in the last four weeks before the trial.
5. Adequate bone marrow, hepatic and renal functional reserves (ANC=1500mm3, PLT=100mm3, GFR=50ml/min by Gault Formula, bilirubin <1.5x, AST/ALT <2.5x upper normal limit or 5x in the presence of hepatic metastases).
6. Patients must be able to swallow pharmaceutical tablets and to be eligible to receive intravenous chemotherapy.
7. Men or women patients must be at least 18 years old.
8. Performance Status Scale 0 or 1 (ECOG).
9. Measurable disease according to RECIST 1.1.
10. Left ventricular ejection fraction (LVEF) =50% (ECHO or MUGA).
11. Provision of patient informed consent for participation in the study and for the use of biological material for research purposes.
12. Willingness and ability to comply with scheduled medical visits, therapeutic treatment programmes, laboratory testing and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
1. Previous systemic first-line therapy.
2. Previous therapy with EGFR/HER TKI or other experimental agent.
3. Diagnosis of a second malignancy, except basal cell carcinoma of the squamous epithelium or in situ carcinoma of any organ, for which an appropriate treatment
has been administered without indications of relapse for 12 months.
4. Presence of uncontrolled, active brain metastases (controlled brain metastases
are considered those that have been irradiated and have remained stable for at
least 4 weeks after radiation therapy).
5. Diagnosis of spinal cord compression or carcinomatous meningitis.
6. Any of the following that has occurred within 12 months before the start of
the study treatment: myocardial infarction, serious or unstable angina pectoris, aortic-coronary or peripheral bypass surgery, symptomatic heart failure, vascular stroke, or transient ischemic attack, or pulmonary embolism.
7. Continuing grade =2 heart rate abnormalities; atrial fibrillation of any grade.
8. Hypertension uncontrolled by medication treatment (>150/100 mm/Hg despite
the administration of best medical therapy).
9. In the case of previous irradiation of locally advanced disease, absence of measurable tumor sites outside the irradiation field.
10. Presence of any other disease which in the opinion of the doctor responsible constitutes a contraindication for the administration of cisplatin, 5FU or afatinib.
11. Diagnosed human immunodeficiency virus (HIV) or disease associated with Acquired Immunodeficiency Syndrome (AIDS).
12. Pregnancy or lactation. Female patients must be surgically sterilised, menopausal, or must consent to use effective contraception throughout the course of the trial.
All female patients with reproduction ability must undergo a pregnancy test (serum or urine). The effective contraceptive technique will be determined by the
main investigator or a person authorized by the investigator.
13. Any other serious, acute or chronic, medical or psychiatric condition or laboratory analysis finding which, in the investigator’s opinion, could create
excessive danger as regards the patient’s participation in the trial or administration of the trial medication may render a patient ineligible for inclusion in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method