Status:
COMPLETED
Efficacy and Safety Study of Combination Therapy With Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status
Lead Sponsor:
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborating Sponsors:
Sanofi
Hoffmann-La Roche
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine efficacy and safety of combination therapy with adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric adenocarcinoma and intermedi...
Eligibility Criteria
Inclusion
- informed consent signed
- Histological or cytological adenocarcinoma confirmation carcinoma on the esophago-gastric union or stomach (type I, II and III Siervent) metastatic or relapsed
- measurable disease (following RECIST criteria)
- older or equal 70 years old
- 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 months
- life expectancy superior to 12 weeks
- adequate hematological function: Neutrophils ≥1.50x109, platelets ≥100x109, Hemoglobin ≥10 g/dl
- 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 ))
- 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
- Potential fertile women negative pregnancy test in serum or urine, 10 days prior the first study dose given
- 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
- non measurable lesion as only disease evidence
- 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
- functional dependency
- hypersensitivity to Docetaxel, oxaliplatin or capecitabine
- previous serious adverse events or unexpected to fluoropirimidin treatment and /or patients with proved deficit in dehidropirimidin deshidrogenase (DPD)
- patients classified as "weak or fragile"
- dependency on one or more of the daily activities following the daily activity scale from Katz
- 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
- 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
- Cardiac concomitant present:
- Symptomatic auriculoventricular arrhythmia history, and /or
- Congestive cardiac insufficiency non controlled by drugs, and / or
- Myocardial infarct 12 months previous the inclusion, and /or
- Symptomatic ischemic cardiopathy
- 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 inclusion)
- severe or bad controlled concomitant disease
- neoplastic history (except skin basocellular or in-situ cervical carcinoma properly treated) in the last 5 years
- patients with any other medical or surgical important problem that, in the investigator opinion, could not allow to follow the treatment
- not able to fulfill the protocol and follow-up
- being involve in any investigational trial with any drug within 4 weeks prior the study treatment
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00733616
Start Date
November 1 2008
End Date
May 1 2012
Last Update
February 20 2013
Active Locations (1)
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1
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain