Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
Inclusion Criteria:
- Written informed consent
- Histologically proven irresectable, metastatic or recurrent adenocarcinoma of the
stomach or the gastroesophageal junction, i.e., Tx-4 M1 or T4 M0
- Irresectable (as judged by an experienced surgeon):
1. T4 infiltrating of several organs
2. T4 infiltrating one organ, but irresectable
3. T4 infiltrating one organ, respectable, but inoperable patient
- The nodal status is neglected
- Measurable disease according to RECIST
- ECOG Performance Status ≤ 2
- Male or female patients aged ≥ 18 years
- Life expectancy ≥ 3 months
- Adequate bone marrow, hepatic and renal function:
1. Haemoglobin > 9.0 g/dL (transfusions allowed to achieve or maintain levels)
2. Absolute neutrophil count > 1.5 x 10^9/L
3. Platelet count > 100 x 10^9/L
4. ALAT, ASAT < 3.5 x ULN
5. Alkaline phosphatase < 6 x ULN
6. Total bilirubin < 1.0 x ULN
7. Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
- Prior surgery must be more than 28 days ago
- Positive nodes as diagnosed on endorectal ultrasound and/or MRI (tumour is staged by
preferably a high resolution MRI; if MRI is not available, locoregional staging must
be performed by computed tomography plus endorectal ultrasound)
- Tumor staging must be done within 28 days from the start of the treatment
- Negative pregnancy test in women with childbearing of potential (within 7 days prior
to the start of the chemotherapy)
- Postmenopausal women must have been amenorrheic for at least 12 months to be
considered of non-childbearing potential
Exclusion Criteria:
- Prior cytotoxic chemotherapy or radiotherapy (a neoadjuvant or adjuvant chemotherapy
must be completed and without progression for at least 6 months)
- Previous (within the last 5 years) or concurrent malignancies, with the exception of
adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the
skin
- Peripheral neuropathy ≥ grade 2 (according to NCI CTCAE v 3.0)
- Patient must not have been treated with any investigational drug, agent nor
procedure, (i.e., did not participate in another trial within 30 days) before entry
in this trial
- Known allergy or any other adverse reaction to any of the study drugs or to any
related compound
- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or
chemically related analogues, such as brivudine
- Clinically significant concomitant diseases, such as:
1. Active infection necessitating systemic antibiotics
2. Interstitial lung diseases
3. Chronic diarrhea, inflammatory bowel disease
4. Neurological or psychiatric disease, dementia, epilepsy or untreated brain
metastases
- Cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease
and cardiac arrhythmia not well controlled with medication) or myocardial infarction
or resuscitation within the last 6 months
- Pregnant or lactating women are excluded
- Presence of adequate contraception in fertile patients (methods of adequate
contraception are: intra-uterine device, hormonal contraception, vasectomy, tubal
ligation or abstinence)
- Alcohol or drug abuse
- Ability to swallow tablets
- Psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule