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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Synthelabo |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00526110 |
Phase I
Primary Objective:
Secondary Objective:
Phase II
Primary Objective:
Secondary Objective:
Condition | Intervention | Phase |
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Gastrointestinal Diseases |
Drug: 5-Fluorouracil Drug: Docetaxel Drug: Oxaliplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Docetaxel, 5-Fluorouracil and Oxaliplatin (D-FOX) in Patients With Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction |
Estimated Enrollment: | 106 |
Study Start Date: | August 2004 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
5-Fluorouracil + Docetaxel + Oxaliplatin
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Drug: 5-Fluorouracil
2.2 Gm/m^2 IV over 48 hours on Day 1.
Drug: Docetaxel
20 mg/m^2 IV over 60 minutes
Drug: Oxaliplatin
85 mg/m^2 IV over 120 minutes on Day 1.
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Oxaliplatin and 5-FU are chemotherapy drugs that are commonly used to treat certain kinds of cancers. Oxaliplatin interferes with the DNA. 5-FU interferes with cell metabolism. Docetaxel interferes with cell division.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will be asked questions about your medical history and have a complete physical exam. You will have around 1 tablespoon of blood drawn for routine tests. You will have your height and weight measured. You will have a chest x-ray and an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will also have a chest x-ray and a CT scan to check the size and location of the tumor. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive treatment with 5-FU as an infusion into a vein using a continuous 24- hour portable pump. This will start on Day 1 and will continue for 48 hours. You will need to carry this pump with you at all times for 48 hours. The pump is about the size of a Sony Walkman®. You will also receive oxaliplatin as an infusion into a vein over 2 hours on Day 1. Docetaxel will be given as an infusion over 60 minutes on Day 1. You will have 12 days to rest between chemotherapy treatments. These drugs may be given to you as an outpatient. Treatment will be repeated on Day 15. Two 14-day treatment periods are called one cycle.
You will be asked to fill out side effect sheets throughout your participation in this research study. You will be asked questions regarding nausea, hair loss, fatigue, meals, and other questions regarding your daily activities. Before each dose of chemotherapy (every 14 days), you will have 1 teaspoon of blood drawn for routine tests.
If the cancer gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
You will be asked to come for a follow-up visit at M.D. Anderson about 2-3 months after treatment ends if possible. At this visit, you will have a full physical, about one tablespoon of blood drawn for routine tests, a chest x-ray, and CT or MRI scans.
This is an investigational study. Oxaliplatin an investigational drug and not approved in the US for use in the treatment of gastric cancer. Docetaxel and 5-FU are commonly used drugs for gastric cancer. The combination of these 3 drugs (docetaxel + oxaliplatin + 5-FU) is investigational. A total of up to 106 patients will take part in this study. All will be enrolled at M.D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Exclusion Criteria:
Contact: Jaffer Ajani, MD | 713-792-2828 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Jaffer Ajani, MD |
Principal Investigator: | Jaffer Ajani, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Jaffer Ajani, MD/Professor ) |
Study ID Numbers: | 2004-0290 |
Study First Received: | September 4, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00526110 |
Health Authority: | United States: Food and Drug Administration |
Gastrointestinal Diseases Adenocarcinoma of the Stomach Gastroesophageal Junction Cancer 5-Fluorouracil |
Docetaxel Oxaliplatin Taxotere Esophagus |
Digestive System Neoplasms Gastrointestinal Diseases Stomach cancer Carcinoma Docetaxel Oxaliplatin Digestive System Diseases |
Stomach Diseases Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |