Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma - Full Text View

Sponsored by:	McGill University
Information provided by:	McGill University
ClinicalTrials.gov Identifier:	NCT00763646

Purpose

The primary purpose of the study is to determine the impact of chemotherapy on the ability of your surgeon to completely remove the cancer as well as the impact on your survival. Furthermore the investigators will be assessing the side effects of this chemotherapy strategy. Finally the investigators will determine the ability of specialized imaging technology (PET scan) to document and predict the response of the tumor to this chemotherapy.

Standard therapy for patients with your condition usually consists of surgery (removal of the tumor) followed by combination chemotherapy and radiotherapy. More recently, standard options available to patients with cancer of the stomach or lower esophagus have been expanded to include chemotherapy without radiotherapy prior to and following surgery. While it is believed that chemotherapy prior to surgery is a good option for patients with stomach, it is not known what is the optimal chemotherapy regimen to offer patients prior to surgery to improve the likelihood of cure while limiting side-effects to patients.

Condition	Intervention	Phase
Gastric Junction Adenocarcinoma Gastroesophageal Junction Adenocarcinoma	Drug: Taxotere, Cisplatin, and 5-FU	Phase II

MedlinePlus related topics: Cancer Radiation Therapy Surgery

Drug Information available for: Fluorouracil Cisplatin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Dose Comparison, Single Group Assignment
Official Title:	Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Further study details as provided by McGill University:

Primary Outcome Measures:

To determine the impact of chemotherapy on the ability of your surgeon to completely remove the cancer as well as the impact on your survival. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Taxotere/Cisplatin/5-FU x 3 cycles (3 weeks per cycle or 9 weeks total), 1 - 2 weeks, Taxotere/Cisplatin/5-FU x 3 cycles (3 weeks per cycle or 9 weeks total)

Eligibility

Ages Eligible for Study:	19 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological diagnosis of adenocarcinoma of the stomach, gastroesophageal junction (GEJ), or lower third of the esophagus.
The tumour must be deemed by the team to be potentially resectable. This includes imaging studies (detailed below) to clinically stage the tumour and rule-out the presence of metastatic disease, and includes a preoperative laparoscopic evaluation.
Stage IB (T1N1 only), II, IIIA, IIIB, and IV (T4N1 only)
Life expectancy greater than 3 months
ECOG performance status of 1 or better (i.e. restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work).
Adequate hematologic reserve: Platelet count 100,000/L, WBC 2000/μL
Creatinine clearance 60 ml/min, AST & ALT 2 ULN, Alkaline phosphatase 2.5 ULN, bilirubin ULN

Exclusion Criteria:

Prior systemic therapy for gastric cancer
Prior docetaxel-containing chemotherapy
Pre-existing medical conditions precluding treatment, including any contraindication for major surgery
Pregnancy or lactating mothers. Women of childbearing age must use contraception during and for 3 months following treatment.
Unable to give informed consent
Patients that are not able to maintain nutrition by oral consumption of food alone must have additional enteral feeding.
Patients with macroscopic disease noted at laparoscopy
ECOG performance status of 2 or higher
Significant hearing impairment, as judged by the need for or use of a hearing aid. If there is any uncertainty regarding the degree of hearing impairment, an audiogram will be done. If the audiogram is grossly normal or shows only minor hearing impairment (i.e. not requiring hearing aid), the patient may be enrolled.
Unwillingness to undergo investigations and/or treatment as outlined on the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763646

Contacts

Contact: Lorenzo Ferri	514-934-1934 ext 44327	lorenzo.ferri@muhc.mcgill.ca
Contact: Steven Ades		steven.ades@vtmednet.org

Locations

Canada, Quebec
McGill University	Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Penny Chipman 514398-1444 penny.chipman@mcgill.ca
Contact: Crystal Lameira 514-398-2229 crystal.lameira@mcgill.ca
Principal Investigator: Lorenzo Ferri

Sponsors and Collaborators

McGill University

Investigators

Principal Investigator:

Lorenzo Ferri

McGill University

More Information

No publications provided

Responsible Party:	McGill University ( Dr. Lorenzo Ferri )
Study ID Numbers:	McG 0620, 116082
Study First Received:	September 30, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00763646
Health Authority:	Canada: Health Canada

Keywords provided by McGill University:

Gastric or Gastroesophageal Junction Adenocarcinoma

Study placed in the following topic categories:

Docetaxel
Cisplatin
Fluorouracil

Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action

Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009