Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511446
Recruitment Status : Completed
First Posted : August 3, 2007
Last Update Posted : June 26, 2013
Information provided by (Responsible Party):
Hans-Joachim Schmoll, MD, Martin-Luther-Universität Halle-Wittenberg

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: docetaxel, oxaliplatin, capecitabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
Study Start Date : August 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: 1
docetaxel, oxaliplatin, capecitabine
Drug: 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.

Other Names:
  • xeloda
  • taxotere
  • eloxatin

Primary Outcome Measures :
  1. Progression-free survival rate [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety/toxicity [ Time Frame: 2 years ]
  2. Median time to progression [ Time Frame: 2 years ]
  3. Response rate [ Time Frame: 2 years ]
  4. Rate of resections with curative intent [ Time Frame: 2 years ]
  5. Time to treatment failure [ Time Frame: 2 years ]
  6. Duration of response [ Time Frame: 2 years ]
  7. Median overall survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511446

Layout table for location information
Charite - Universitatsmedizin Berlin
Berlin, Germany, 13353
Medizinische Universitätsklinik - Knappschaftskrankenhaus
Bochum, Germany, 44892
Städtische Kliniken Esslingen
Esslingen, Germany, 73730
MVZ Osthessen
Fulda, Germany, 36043
Martin-Luther-University Halle-Wittenberg
Halle (Saale), Germany, 06120
Städt. Klinikum St. Georg
Leipzig, Germany, 04129
OSP Lörrach-Rheinfelden
Lörrach, Germany, 79539
Universitätsklinikum Mainz
Mainz, Germany, 55101
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Universitätsklinik Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Layout table for investigator information
Principal Investigator: Hans-Joachim Schmoll, Prof. Dr. Martin-Luther-University Halle-Wittenberg, Medical Faculty

Additional Information:
Layout table for additonal information
Responsible Party: Hans-Joachim Schmoll, MD, MD, Martin-Luther-Universität Halle-Wittenberg Identifier: NCT00511446     History of Changes
Other Study ID Numbers: AIO STO-0601
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013
Keywords provided by Hans-Joachim Schmoll, MD, Martin-Luther-Universität Halle-Wittenberg:
Stomach neoplasms
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic