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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00816543
First received: December 31, 2008
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.

Condition Intervention Phase
Gastric Cancer
Drug: DOCETAXEL
Drug: S-1
Drug: OXALIPLATIN
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • R0 resection rate [ Time Frame: At the end of the treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical examination [ Time Frame: Every 3 months during the study period ] [ Designated as safety issue: No ]
  • Chest X-Ray [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Computed Tomography scan of the abdomen [ Time Frame: Every 6 months during the study period ] [ Designated as safety issue: No ]
  • Gastrofiberscopy [ Time Frame: Every 1 year from the completion of the treatment for 2 years ] [ Designated as safety issue: No ]
  • Laboratory analysis [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: December 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
Drug: DOCETAXEL
50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
Drug: 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.
Drug: OXALIPLATIN
100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816543

Locations
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Faith Fung Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00816543     History of Changes
Other Study ID Numbers: DOCET_R_03761
Study First Received: December 31, 2008
Last Updated: December 17, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014