Docetaxel + Oxaliplatin + S-1 in Neoadjuvant Gastric Cancer - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00816543

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
Esophageal Neoplasms	Drug: DOCETAXEL Drug: S-1 Drug: OXALIPLATIN	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Oxaliplatin Docetaxel S 1 (Combination)

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	41
Study Start Date:	December 2008
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

Contacts

Contact: Public Registry GMA

PublicRegistryGMA@sanofi-aventis.com

Locations

Korea, Republic of
Sanofi-aventis Administrative Office	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Faith Fung

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	DOCET_R_03761
Study First Received:	December 31, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00816543 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Docetaxel
Oxaliplatin
Digestive System Diseases

Esophageal Disorder
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Stomach Cancer
Adenocarcinoma

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Pharmacologic Actions
Docetaxel
Neoplasms

Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Head and Neck Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 02, 2009