Clinical trial NCT00511446: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: Stomach neoplasms
docetaxel
oxaliplatin
capecitabine
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2007-08-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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):

  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

Primary outcomes:
measure: Progression-free survival rate
timeFrame: at 6 months
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety/toxicity
timeFrame: 2 years
measure: Median time to progression
timeFrame: 2 years
measure: Response rate
timeFrame: 2 years
measure: Rate of resections with curative intent
timeFrame: 2 years
measure: Time to treatment failure
timeFrame: 2 years
measure: Duration of response
timeFrame: 2 years
measure: Median overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin
city: Bochum
country: Germany
facility: Medizinische Universitätsklinik - Knappschaftskrankenhaus
city: Esslingen
country: Germany
facility: Städtische Kliniken Esslingen
city: Fulda
country: Germany
facility: MVZ Osthessen
city: Halle (Saale)
country: Germany
facility: Martin-Luther-University Halle-Wittenberg
city: Leipzig
country: Germany
facility: Städt. Klinikum St. Georg
city: Lörrach
country: Germany
facility: OSP Lörrach-Rheinfelden
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Ulm
country: Germany
facility: Universitätsklinik Ulm
Study officials:
affiliation: Martin-Luther-University Halle-Wittenberg, Medical Faculty
name: Hans-Joachim Schmoll, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: