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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hans-Joachim Schmoll, MD, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00511446
First received: August 2, 2007
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Stomach Neoplasms
Drug: docetaxel, oxaliplatin, capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Progression-free survival rate [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety/toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Median time to progression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Rate of resections with curative intent [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Time to treatment failure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Median overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: August 2007
Study Completion Date: January 2013
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511446

Locations
Germany
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
Investigators
Principal Investigator: Hans-Joachim Schmoll, Prof. Dr. Martin-Luther-University Halle-Wittenberg, Medical Faculty
  More Information

Additional Information:
No publications provided

Responsible Party: Hans-Joachim Schmoll, MD, MD, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00511446     History of Changes
Other Study ID Numbers: AIO STO-0601
Study First Received: August 2, 2007
Last Updated: June 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
Stomach neoplasms
docetaxel
oxaliplatin
capecitabine

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases
Capecitabine
Docetaxel
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014