Know Cancer

forgot password

Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer

Phase 2
18 Years
Not Enrolling
Stomach Neoplasms

Thank you

Trial Information

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate

Outcome Time Frame:

at 6 months

Safety Issue:


Principal Investigator

Hans-Joachim Schmoll, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Martin-Luther-University Halle-Wittenberg, Medical Faculty


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AIO STO-0601



Start Date:

August 2007

Completion Date:

January 2013

Related Keywords:

  • Stomach Neoplasms
  • Stomach neoplasms
  • docetaxel
  • oxaliplatin
  • capecitabine
  • Neoplasms
  • Stomach Neoplasms