AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
- Conditions
- nrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinomaMedDRA version: 14.1 Level: LLT Classification code 10017759 Term: Gastric cancer in situ System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-001605-42-GB
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 138
Inclusion Criteria
4.1.1 Disease related
• Pathologically confirmed unresectable locally advanced or metastatic gastric or
esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus
within 5 cm of the EGJ are eligible
• ECOG performance status 0 or 1
• Life expectancy = 3 months
4.1.2 Demographic
• Male or female = 18 years of age
4.1.3 Ethical
• Before any study-specific procedure, the appropriate written informed consent
must be obtained (see Section 12.1)
4.1.4 Laboratory
• Hemoglobin = 9 g/dL (can be post-transfusion)
• Absolute neutrophil count = 1.5 x 109/L
• Platelet count = 100 x 109/L (without transfusion within 14 days before enrollment
or randomization)
• Creatinine clearance = 60 mL/minute (calculated or measured)
• Aspartate aminotransferase (AST) and alanine amino transferase (ALT) = 2.5 x
ULN (OR AST and ALT = 5.0 x ULN in the presence of liver metastasis)
• Total bilirubin = 1.5x ULN
• Partial thromboplastin time (PTT) = 1.5 x ULN and international normalized ratio
(INR) = ULN
4.1.5 General
• Plan to begin protocol specific therapy within 7 days after enrollment or
randomization
• Able to tolerate infusions and take oral medications
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 82
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39
Exclusion Criteria
4.2.1 Disease Related
• Previous systemic therapy (chemotherapy or biologic therapy) for locally
advanced or metastatic gastric or esophagogastric adenocarcinoma
• Less than 6 months have elapsed from completion of prior neoadjuvant or
adjuvant chemotherapy or chemoradiotherapy. Patients previously treated with
anthracyclines must not exceed total cumulative dose of epirubicin of 900 mg/m2
(or equivalent thereof, if a different anthracycline has been administered in the
past) including doses to be administered in this trial.
• Any prior or synchronous malignancy (except for non-melanomatous skin cancer
or in situ cervical cancer) other than the study disease, unless treated with
curative intent and having completed all therapy with no evidence of disease = 5
years before enrollment or randomization
• Known peripheral neuropathy > grade 1
• Known dihydropyrimidine dehydrogenase deficiency (DPD)
• Any clinically significant medical condition other than cancer, including cardiovascular disease or chronic obstructive pulmonary disease (COPD), which in the opinion of the investigator would interfere with the safe delivery of study
treatment or increase risk of toxicity
• History of any medical condition that in the opinion of the investigator, may
increase the risks associated with study participation or study treatments or may
interfere with the conduct of the study or interpretation of study results
• Major surgical procedure = 30 days before enrollment or randomization or not yet
recovered from prior major surgery
• Minor surgery (e,g. catheter or gastrostomy tube placement) =14 days before
enrollment or randomization or not yet recovered from prior minor surgery;
although placement of central venous access device, fine needle aspiration,
thoracentesis, endoscopic biliary stent or paracentesis = 1 day before enrollment
or randomization is acceptable
• Subjects with resectable disease or suitable for definitive chemoradiation
• Plans for surgical resection based on response to protocol therapy
• Subjects who have persistent gastric outlet obstruction, complete dysphagia or
are dependent upon jejunostomy for feeding.
• Tumors of squamous cell histology
• Treatment with radiotherapy = 14 days before enrollment or randomization
• Known central nervous system metastases
• Clinically significant upper gastro-intestinal bleeding < 30 days prior to enrollment
or randomization
4.2.2 Cardiac
• LVEF < 50% as determined by either MUGA scan or ECHO
• Clinically significant (i.e. active) cardiac disease or myocardial infarction within
the last 12 months before enrollment or randomization. Patients with any history
of clinically significant cardiac failure are excluded from study entry
4.2.3 Other abnormal medical co
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