Stomach Neoplasms
Conditions
Keywords
Stomach neoplasms, docetaxel, oxaliplatin, capecitabine
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.
Interventions
DRUGdocetaxel, 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.
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Median time to progression | 2 years |
| Response rate | 2 years |
| Rate of resections with curative intent | 2 years |
| Number of Participants with Adverse Events as a Measure of Safety/toxicity | 2 years |
| Duration of response | 2 years |
| Median overall survival | 2 years |
| Time to treatment failure | 2 years |
Countries
Germany
Outcome results
None listed