Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma

Sanofi

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

Treatments

Drug: S-1

Drug: OXALIPLATIN

Drug: DOCETAXEL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00816543

DOCET_R_03761

Details and patient eligibility

About

The primary objective of this trial is:

To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved.

The secondary objective of this trial are to describe:

The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection.
The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.

Enrollment

41 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-esophageal adenocarcinoma, that is considered operable.
- The bulk of disease must be localized in the stomach, although the gastroesophageal junction may be involved.
- Patients with T3 or T4 carcinoma without (N0) and T2 or T3 or T4 with regional lymph node involvement assessed by EUS, no peritoneal seeding suspected on abdomen-pelvic CT or confirmed by laparoscopy.
Performance status 0-1 in ECOG scale
Adequate haematological function and liver and kidney function within 7 days prior to enrollment:
- Absolute neutrophil count > or = 1.5 x 10^9/L
- Platelets > or = 100 x 10^9/L
- Haemoglobin > 10 g/dl
- Calculated creatinine clearance > or = 60 ml/min
- Total bilirubin < or = 3 x UNL
- GOT and GPT < or = 3 x UNL

Exclusion Criteria

Previous surgery on primary tumour
Prior palliative surgery (open and closure, passage operation)
Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated
Distant metastases (M1) including distant nodal Groups (Retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node)
Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy
Simultaneous therapy with other anti-tumour drugs
Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine, indications of resorption disorders after intestinal surgery
Evidence of gastric outlet obstruction and /or severe tumor hemorrhage
Other anamnestic reaction, serious illness or other medical conditions:
- Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
- Chronic diarrhoea
- Neurological or psychological disorders including dementia and seizures
- Active, non-controllable infection or sepsis
- Actively disseminated intravascular coagulation
Symptomatic peripheral neuropathy NCI CTC version 3.0 grade > or = 1
Hypersensitivity to study drugs
Patients under anticoagulant therapy with warfarin or other coumarines are excluded from participation.
Pregnant or lactating (in case of potentially childbearing woman, pregnancy test is positive)
Patients of child-bearing age or the potential to father a child who refuse to use adequate contraception
Drug, substance or alcohol abuse