Efficacy and Safety Study of Combination Therapy With Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733616
• Other study ID #: TTD-08-02
• Secondary ID: EudraCT Nº: 2008
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2008
• Last updated: February 19, 2013
• Start date: November 2008
• Est. completion date: May 2012

Study information

• Verified date: February 2013
• Source: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer

Intervention

Drug:
• DOX: Docetaxel, oxaliplatin, Capecitabine
Docetaxel 40 mg/m2, iv infusion 60 minutes, day 1 Oxaliplatin 80 mg/m2, iv infusion 120 minutes, day 1 Capecitabine 625 mg/m2, bid, oral, continuous 6 cycles, every 3 weeks Capecitabine will be given same dose (625mg/m2/bid) continuous in case no toxicity (no dose adjustment)

Locations

Country	Name	City	State
Spain	Spanish Cooperative Group for Gastrointestinal Tumour Therapy	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)	Hoffmann-La Roche, Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		2008-2011	No
Secondary	adverse events		2008-2011	Yes
Secondary	Progression free survival (PFS), time to treatment failure (TTF), overall survival and dose intensity		2008-2011	No