Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
docetaxel, oxaliplatin, capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach neoplasms, docetaxel, oxaliplatin, capecitabine
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):
- 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
- ALAT, ASAT < 3.5 x ULN
- Alkaline phosphatase < 6 x ULN
- Total bilirubin < 1.0 x ULN
- 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:
- 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
- Ability to swallow tablets
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Sites / Locations
- Charite - Universitatsmedizin Berlin
- Medizinische Universitätsklinik - Knappschaftskrankenhaus
- Städtische Kliniken Esslingen
- MVZ Osthessen
- Martin-Luther-University Halle-Wittenberg
- Städt. Klinikum St. Georg
- OSP Lörrach-Rheinfelden
- Universitätsklinikum Mainz
- Universitätsklinikum Mannheim
- Universitätsklinik Ulm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
docetaxel, oxaliplatin, capecitabine
Outcomes
Primary Outcome Measures
Progression-free survival rate
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety/toxicity
Median time to progression
Response rate
Rate of resections with curative intent
Time to treatment failure
Duration of response
Median overall survival
Full Information
NCT ID
NCT00511446
First Posted
August 2, 2007
Last Updated
June 25, 2013
Sponsor
Martin-Luther-Universität Halle-Wittenberg
1. Study Identification
Unique Protocol Identification Number
NCT00511446
Brief Title
Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
Official Title
Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach neoplasms, docetaxel, oxaliplatin, capecitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
docetaxel, oxaliplatin, capecitabine
Intervention Type
Drug
Intervention Name(s)
docetaxel, oxaliplatin, capecitabine
Other Intervention Name(s)
xeloda, taxotere, eloxatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival rate
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety/toxicity
Time Frame
2 years
Title
Median time to progression
Time Frame
2 years
Title
Response rate
Time Frame
2 years
Title
Rate of resections with curative intent
Time Frame
2 years
Title
Time to treatment failure
Time Frame
2 years
Title
Duration of response
Time Frame
2 years
Title
Median overall survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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):
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
ALAT, ASAT < 3.5 x ULN
Alkaline phosphatase < 6 x ULN
Total bilirubin < 1.0 x ULN
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:
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
Ability to swallow tablets
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Joachim Schmoll, Prof. Dr.
Organizational Affiliation
Martin-Luther-University Halle-Wittenberg, Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite - Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medizinische Universitätsklinik - Knappschaftskrankenhaus
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Städtische Kliniken Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
MVZ Osthessen
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
Martin-Luther-University Halle-Wittenberg
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Städt. Klinikum St. Georg
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
OSP Lörrach-Rheinfelden
City
Lörrach
ZIP/Postal Code
79539
Country
Germany
Facility Name
Universitätsklinikum Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitätsklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.aio-portal.de
Description
Arbeitsgemeinschaft Internistische Onkologie
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Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
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