Stomach NeoplasmsPhase 2NCT00511446
Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
A Phase 2 study testing docetaxel, oxaliplatin, capecitabine in people with Stomach Neoplasms, run by Martin-Luther-Universität Halle-Wittenberg at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- docetaxel, oxaliplatin, capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 10 sitesGermany
- Study dates
- Aug 2007to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Charite - Universitatsmedizin Berlin
Berlin, 13353
Medizinische Universitätsklinik - Knappschaftskrankenhaus
Bochum, 44892
Städtische Kliniken Esslingen
Esslingen am Neckar, 73730
MVZ Osthessen
Fulda, 36043
Martin-Luther-University Halle-Wittenberg
Halle, 06120
Städt. Klinikum St. Georg
Leipzig, 04129
OSP Lörrach-Rheinfelden
Loerrach, 79539
Universitätsklinikum Mainz
Mainz, 55101
Universitätsklinikum Mannheim
Mannheim, 68167
Universitätsklinik Ulm
Ulm, 89081
About this study
Official title: Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
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
- Being tested
- docetaxel, oxaliplatin, capecitabine
- Keywords
- Stomach neoplasms, docetaxel, oxaliplatin, capecitabine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel, oxaliplatin, capecitabineDrug
Also called xeloda, taxotere, eloxatin
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | docetaxel, oxaliplatin, capecitabine Receives: Drug: docetaxel, oxaliplatin, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
Measured: at 6 months
Secondary outcomes (7)
Number of Participants with Adverse Events as a Measure of Safety/toxicity
Measured: 2 years
Median time to progression
Measured: 2 years
Response rate
Measured: 2 years
Rate of resections with curative intent
Measured: 2 years
Time to treatment failure
Measured: 2 years
Duration of response
Measured: 2 years
Median overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2010
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans-Joachim Schmoll, MD, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Hans-Joachim Schmoll, Prof. Dr., Principal investigator, Martin-Luther-University Halle-Wittenberg, Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511446
- Sponsor's protocol ID
- AIO STO-0601
- Status last verified
- Jun 2013
- First submitted
- 2 Aug 2007
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Docetaxel, Oxaliplatin and Capecitabine (TEX) in Advanced or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00511446
- Acronym / sponsor ID
- AIO STO-0601
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach neoplasms, docetaxel, oxaliplatin, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: docetaxel, oxaliplatin, capecitabinedocetaxel, oxaliplatin, capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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):
- The nodal status is neglected
- Measurable disease according to RECIST
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel, oxaliplatin, capecitabineAlso: xeloda, taxotere, eloxatinDocetaxel: 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. | Drug | 1 |
Primary outcome
Progression-free survival rate
Time frame: at 6 months
7 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety/toxicity
Time frame: 2 years
Median time to progression
Time frame: 2 years
Response rate
Time frame: 2 years
Rate of resections with curative intent
Time frame: 2 years
Time to treatment failure
Time frame: 2 years
Duration of response
Time frame: 2 years
Median overall survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
- Arbeitsgemeinschaft Internistische OnkologieLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Joachim Schmoll, Prof. Dr. principal investigator
Martin-Luther-University Halle-Wittenberg, Medical Faculty
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, oxaliplatin, capecitabine in people with Stomach Neoplasms, run by Martin-Luther-Universität Halle-Wittenberg at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.