NCT00733616

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

3.5 years

First QC Date

August 12, 2008

Last Update Submit

February 19, 2013

Conditions

Gastric Cancer

Keywords

advanced gastric adenocarcinomadocetaxeloxaliplatincapecitabineintermediate general status

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    2008-2011

Secondary Outcomes (2)

  • adverse events

    2008-2011

  • Progression free survival (PFS), time to treatment failure (TTF), overall survival and dose intensity

    2008-2011

Study Arms (1)

1

EXPERIMENTAL
Drug: DOX: Docetaxel, oxaliplatin, Capecitabine

Interventions

DOX: Docetaxel, oxaliplatin, CapecitabineDRUG

* 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)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • non measurable lesion as only disease evidence
  • 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
  • Symptomatic ischemic cardiopathy
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25491381DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

OxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Fernando Rivera, MD; phD

    Hospital Marques de Valdecilla. Santander. Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 13, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

ES(1)