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

Gastric Cancer Clinical Trial

Official title:

A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816543
• Other study ID #: DOCET_R_03761
• Status: Completed
• Phase: Phase 2
• First received: December 31, 2008
• Last updated: December 17, 2012
• Start date: December 2008
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer

Intervention

Drug:
• DOCETAXEL
50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
• S-1
80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.
• OXALIPLATIN
100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate		At the end of the treatment period	No
Secondary	Physical examination		Every 3 months during the study period	No
Secondary	Chest X-Ray		Throughout the study period	No
Secondary	Computed Tomography scan of the abdomen		Every 6 months during the study period	No
Secondary	Gastrofiberscopy		Every 1 year from the completion of the treatment for 2 years	No
Secondary	Laboratory analysis		Throughout the study period	No