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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00733616

Enrollment

Registered

2008-08-13

Start date

2008-11-30

Completion date

2012-05-31

Last updated

2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

advanced gastric adenocarcinoma, docetaxel, oxaliplatin, capecitabine, intermediate general status

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)

Interventions

DRUGDOX: 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
objective response rate	2008-2011

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026