Inoperable gastric and gastroesophageal junction cancer MedDRA version: 15.0 Level: LLT Classification code 10017760 Term: Gastric cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Afatinib
Product Code: BIBW 2992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: afatinib
CAS Number: 850140-72-6
Current Sponsor code: BIBW 2992
Other descriptive name: AFA
Sponsors
Hellenic Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the activity of the combination mCisFU-A (modified cisplatin, 5FU, afatinib) in patients with inoperable, locally advanced or metastatic gastric or gastroesophageal adenocarcinoma in terms of objective response, in accordance with RECIST 1.1. ;Secondary Objective: •To evaluate the activity of the combination mCisFU-A in patients with inoperable, locally advanced, or metastatic gastric or gastroesophageal adenocarcinoma in terms of Progression Free Survival (PFS) and Overall Survival (OS). •To evaluate the safety, adverse event profile and tolerance of the combination mCisFU-A in the trial patient population. •Exploratory objective To investigate the correlations between potential biological markers and clinical results, with the objective of detecting biological markers of prognostic and predictive significance for patient outcomes, response to therapy, and toxicity.;Primary end point(s): Objective Response Rate (ORR) according to RECIST 1.1.;Timepoint(s) of evaluation of this end point: Imaging techniques will be performed once every 8 weeks during the administration of cisplatin-5FU-afatinib combination, and once every 12 weeks in the maintenance phase with afatinib monotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall Survival (OS) 2. Progression-Free Survival (PFS) 3. Safety 4. Exploratory: Immunochemical expression of proteins/mRNA of the tumor that can be linked to the efficacy / safety of the treatment, the tumor angiogenesis and the mechanism of action of the combination cisplatin/5FU/Afatinib;Timepoint(s) of evaluation of this end point: 1. Overall survival (OS) will be calculated from the date of treatment initiation to the date of death from any cause. 2. Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of disease progression, or date of death from cancer or any other cause in the event that there is no confirmed disease progression, or the date of the last monitoring, depending on which of the above will be the initial occurrence. 3. Evaluation of Adverse Events (AEs) will be performed: On Day 1 and day 10 in cycle 1 On Day 1 in cycles 2-6 (q 21 days) On Day 1 during maintenance treatment with afatinib (q 4 weeks) 4. Before treatment initiation | — |
Countries
Greece
Contacts
Public ContactClinical Trials
Hellenic Cooperative Oncology Group
Outcome results
None listed