Clinical trial NCT00733616: Efficacy and Safety Study of Combination Therapy With Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status
Official title: Phase II Study of Adjusted-dose Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: advanced gastric adenocarcinoma
docetaxel
oxaliplatin
capecitabine
intermediate general status
Lead sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Hoffmann-La Roche
First posted: 2008-08-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 intermediate general status.(defined as ECOG 2 or weight loss 10-25% or older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)


Eligibility criteria: 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 relapsed
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 months
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 inclusion)
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

Primary outcomes:
measure: objective response rate
timeFrame: 2008-2011
Secondary outcomes:
measure: adverse events
timeFrame: 2008-2011
measure: Progression free survival (PFS), time to treatment failure (TTF), overall survival and dose intensity
timeFrame: 2008-2011
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Study officials:
affiliation: Hospital Marques de Valdecilla. Santander. Spain
name: Fernando Rivera, MD; phD
role: STUDY_CHAIR
References:
citation: Rivera F, Massuti B, Salcedo M, Sastre J, Martinez Galan J, Valladares-Ayerbes M, Serrano R, Garcia de Paredes ML, Manzano JL, Galan M, Alsina M, Yuste Izquierdo AL, Lopez C, Diaz-Rubio E, Conde V, Reboredo M, Cano MT, Pachon V, Aranda E. Phase II trial of miniDOX (reduced dose docetaxel-oxaliplatin-capecitabine) in "suboptimal" patients with advanced gastric cancer (AGC). TTD 08-02. Cancer Chemother Pharmacol. 2015 Feb;75(2):319-24. doi: 10.1007/s00280-014-2641-3. Epub 2014 Dec 10.