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Phase II Study of Adjusted-dose Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status.

Phase 2
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

Phase II Study of Adjusted-dose Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status.

Inclusion Criteria:

1. informed consent signed

2. Histological or cytological adenocarcinoma confirmation carcinoma on the
esophago-gastric union or stomach (type I, II and III Siervent) metastatic or

3. measurable disease (following RECIST criteria)

4. older or equal 70 years old

5. Intermediate general status defined as at least one of the following characteristics:
performance status (ECOG) = 2, weight loss ponderada between 10 and 25% in the last 3

6. life expectancy superior to 12 weeks

7. adequate hematological function: Neutrophils ≥1.50x109, platelets ≥100x109,
Hemoglobin ≥10 g/dl

8. adequate liver function: Liver function (total bilirubine < 2 NV; GOT y GPT <3 NV (<
5 NV in case of liver metastasis; Alkaline phosphatase <3 NV ))

9. Adequate renal function: renal function (Creatinine clearance > 50mL/min), based on
Cockroff - Gault. In case Creatinine clearance is < 50 ml/min, a test in urine will
be done in 24 hours and if the value is > 50 ml/min, the patient could be eligible
for the study

10. Potential fertile women negative pregnancy test in serum or urine, 10 days prior the
first study dose given

11. Use an adequate contraceptive method (postmenopausal women should be amenorrheic at
least 12 months previous the study to be considered as not potentially fertile
(VN:upper limit on normal laboratory values)

Exclusion Criteria:

1. non measurable lesion as only disease evidence

2. previous chemotherapy treatment for advance disease. It wont´t be consider as
exclusion criteria if chemo or radiotherapy has been given for localized disease and
finished more than 1 year ago. In caso os only measurable disease in the radiated
area, progressive disease has to be documented previous to the inclusion

3. functional dependency

4. hypersensitivity to Docetaxel, oxaliplatin or capecitabine

5. previous serious adverse events or unexpected to fluoropirimidin treatment and /or
patients with proved deficit in dehidropirimidin deshidrogenase (DPD)

6. patients classified as "weak or fragile"

1. dependency on one or more of the daily activities following the daily activity
scale from Katz

2. three or more comorbitities of the following: congestive cardiac insufficiency,
cardiac valvulopathy, coronaripathia, chronic pulmonary disease (obstructive or
restrictive), cerebrovascular disease, diabetes, concomitant neoplasms, collagen
vascular disease, chronic hetopathy and incapacitate arthritis

3. presence of geriatric syndromes: moderate-severe dementia, stress delirium
(urinary respiratory infection); moderate-severe depression that interfere in
the habitual daily life; frequent falls (3 or more monthly); be disattended;
urinary incontinence, without stress, infection, diuretics or prostatic
hyperplasia; fecal incontinence without diarrhea or laxative; osteoporotic
fracture of long bone or vertebral squash

7. Cardiac concomitant present:

1. Symptomatic auriculoventricular arrhythmia history, and /or

2. Congestive cardiac insufficiency non controlled by drugs, and / or

3. Myocardial infarct 12 months previous the inclusion, and /or

4. Symptomatic ischemic cardiopathy

8. active infectious process ((leukocytes superior to 12 x 109/l or fever upper to 38º,
it is required thorax X:ray, hemoculture and urine culture 5 days previous to the

9. severe or bad controlled concomitant disease

10. neoplastic history (except skin basocellular or in-situ cervical carcinoma properly
treated) in the last 5 years

11. patients with any other medical or surgical important problem that, in the
investigator opinion, could not allow to follow the treatment

12. not able to fulfill the protocol and follow-up

13. being involve in any investigational trial with any drug within 4 weeks prior the
study treatment

Type of Study:


Study Design:

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

Outcome Measure:

objective response rate

Outcome Time Frame:


Safety Issue:


Principal Investigator

Fernando Rivera, MD; phD

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Marques de Valdecilla. Santander. Spain


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

November 2008

Completion Date:

May 2012

Related Keywords:

  • Gastric Cancer
  • advanced gastric adenocarcinoma
  • docetaxel
  • oxaliplatin
  • capecitabine
  • intermediate general status
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms