Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
1 other identifier
interventional
56
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2007
Longer than P75 for phase_2
10 active sites
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
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 2, 2007
CompletedFirst Posted
Study publicly available on registry
August 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 26, 2013
June 1, 2013
2.8 years
August 2, 2007
June 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival rate
at 6 months
Secondary Outcomes (7)
Number of Participants with Adverse Events as a Measure of Safety/toxicity
2 years
Median time to progression
2 years
Response rate
2 years
Rate of resections with curative intent
2 years
Time to treatment failure
2 years
- +2 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALdocetaxel, oxaliplatin, capecitabine
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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):
- T4 infiltrating of several organs
- T4 infiltrating one organ, but irresectable
- 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:
- Haemoglobin \> 9.0 g/dL (transfusions allowed to achieve or maintain levels)
- Absolute neutrophil count \> 1.5 x 10\^9/L
- Platelet count \> 100 x 10\^9/L
- +9 more criteria
You may not qualify if:
- 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:
- Active infection necessitating systemic antibiotics
- Interstitial lung diseases
- Chronic diarrhea, inflammatory bowel disease
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Charite - Universitatsmedizin Berlin
Berlin, 13353, Germany
Medizinische Universitätsklinik - Knappschaftskrankenhaus
Bochum, 44892, Germany
Städtische Kliniken Esslingen
Esslingen am Neckar, 73730, Germany
MVZ Osthessen
Fulda, 36043, Germany
Martin-Luther-University Halle-Wittenberg
Halle, 06120, Germany
Städt. Klinikum St. Georg
Leipzig, 04129, Germany
OSP Lörrach-Rheinfelden
Loerrach, 79539, Germany
Universitätsklinikum Mainz
Mainz, 55101, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
Universitätsklinik Ulm
Ulm, 89081, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans-Joachim Schmoll, Prof. Dr.
Martin-Luther-University Halle-Wittenberg, Medical Faculty
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 2, 2007
First Posted
August 3, 2007
Study Start
August 1, 2007
Primary Completion
May 1, 2010
Study Completion
January 1, 2013
Last Updated
June 26, 2013
Record last verified: 2013-06