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

February 19, 2013 updated by: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: 2008-2011
2008-2011

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 2008-2011
2008-2011
Progression free survival (PFS), time to treatment failure (TTF), overall survival and dose intensity
Time Frame: 2008-2011
2008-2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Collaborators

Sanofi
Hoffmann-La Roche

Investigators

  • Study Chair: Fernando Rivera, MD; phD, Hospital Marques de Valdecilla. Santander. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTD-08-02
  • EudraCT Nº: 2008-001825-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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