Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer

NCT ID: NCT00511446

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2013-01-31

Brief Summary

Combination regimens of 3 active drugs have shown promising activity in treatment of metastatic gastric cancer. Docetaxel combined with cisplatin and 5-fluorouracil (FU) yielded superior overall survival and response rates when compared to standard cisplatin and 5-FU. However, a toxicity profile showed the need for development of less toxic modifications. In a prior phase I trial, the maximum tolerated dose was defined. In this phase II trial, a first evaluation of activity will be performed.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

docetaxel, oxaliplatin, capecitabine

Group Type: EXPERIMENTAL

docetaxel, oxaliplatin, capecitabine

Intervention Type: DRUG

Docetaxel: 35 mg/m2, IV day 1, 8 of each 21 day cycle; Oxaliplatin: 70 mg/m2, IV day 1, 8 of each 21 day cycle; Capecitabine: 2x800 mg/m2 PO IV day 1 evening till morning of day 15 of each 21 day cycle.

Number of Cycles: until progression or unacceptable toxicity develops.

Interventions

docetaxel, oxaliplatin, capecitabine

Docetaxel: 35 mg/m2, IV day 1, 8 of each 21 day cycle; Oxaliplatin: 70 mg/m2, IV day 1, 8 of each 21 day cycle; Capecitabine: 2x800 mg/m2 PO IV day 1 evening till morning of day 15 of each 21 day cycle.

Number of Cycles: until progression or unacceptable toxicity develops.

Intervention Type: DRUG

Other Intervention Names

xeloda; taxotere; eloxatin

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Histologically proven irresectable, metastatic or recurrent adenocarcinoma of the stomach or the gastroesophageal junction, i.e., Tx-4 M1 or T4 M0
• Irresectable (as judged by an experienced surgeon):

1. T4 infiltrating of several organs

2. T4 infiltrating one organ, but irresectable

3. T4 infiltrating one organ, respectable, but inoperable patient

• The nodal status is neglected
• Measurable disease according to RECIST
• ECOG Performance Status ≤ 2
• Male or female patients aged ≥ 18 years
• Life expectancy ≥ 3 months
• Adequate bone marrow, hepatic and renal function:

1. Haemoglobin > 9.0 g/dL (transfusions allowed to achieve or maintain levels)

2. Absolute neutrophil count > 1.5 x 10^9/L

3. Platelet count > 100 x 10^9/L

4. ALAT, ASAT < 3.5 x ULN

5. Alkaline phosphatase < 6 x ULN

6. Total bilirubin < 1.0 x ULN

7. Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)

• Prior surgery must be more than 28 days ago
• Positive nodes as diagnosed on endorectal ultrasound and/or MRI (tumour is staged by preferably a high resolution MRI; if MRI is not available, locoregional staging must be performed by computed tomography plus endorectal ultrasound)
• Tumor staging must be done within 28 days from the start of the treatment
• Negative pregnancy test in women with childbearing of potential (within 7 days prior to the start of the chemotherapy)

• Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential

Exclusion Criteria

• Prior cytotoxic chemotherapy or radiotherapy (a neoadjuvant or adjuvant chemotherapy must be completed and without progression for at least 6 months)
• Previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
• Peripheral neuropathy ≥ grade 2 (according to NCI CTCAE v 3.0)
• Patient must not have been treated with any investigational drug, agent nor procedure, (i.e., did not participate in another trial within 30 days) before entry in this trial
• Known allergy or any other adverse reaction to any of the study drugs or to any related compound
• Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine
• Clinically significant concomitant diseases, such as:

1. Active infection necessitating systemic antibiotics

2. Interstitial lung diseases

3. Chronic diarrhea, inflammatory bowel disease

4. Neurological or psychiatric disease, dementia, epilepsy or untreated brain metastases

• Cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction or resuscitation within the last 6 months
• Pregnant or lactating women are excluded
• Presence of adequate contraception in fertile patients (methods of adequate contraception are: intra-uterine device, hormonal contraception, vasectomy, tubal ligation or abstinence)
• Alcohol or drug abuse
• Ability to swallow tablets
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: lead

Responsible Party

Hans-Joachim Schmoll, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans-Joachim Schmoll, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Martin-Luther-University Halle-Wittenberg, Medical Faculty

Locations

Charite - Universitatsmedizin Berlin

Berlin, , Germany

Medizinische Universitätsklinik - Knappschaftskrankenhaus

Bochum, , Germany

Städtische Kliniken Esslingen

Esslingen am Neckar, , Germany

MVZ Osthessen

Fulda, , Germany

Martin-Luther-University Halle-Wittenberg

Halle, , Germany

Städt. Klinikum St. Georg

Leipzig, , Germany

OSP Lörrach-Rheinfelden

Loerrach, , Germany

Universitätsklinikum Mainz

Mainz, , Germany

Universitätsklinikum Mannheim

Mannheim, , Germany

Universitätsklinik Ulm

Ulm, , Germany

Countries

Germany

Related Links

http://www.aio-portal.de

Arbeitsgemeinschaft Internistische Onkologie

Other Identifiers

AIO STO-0601

Identifier Type: -

Identifier Source: org_study_id