Gastrointestinal Diseases Clinical Trial
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
Phase I Objectives
Primary:
1. The primary objective of this study is to determine the maximum tolerated dose (MTD) of
Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated,
locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal
junction (GEJ).
Secondary:
1. To determine the qualitative and quantitative toxicity and reversibility of toxicity of
this combination.
Phase II Objectives
Primary:
1. To assess time to cancer progression to D-FOX treatment regimen.
Secondary:
1. To assess response rate to D-FOX treatment regimen.
2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of
this combination treatment regimen.
3. Determine overall survival.
4. Perform an exploratory investigation into the effect of D-FOX on phenotypic
abnormalities in blood.
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 computed tomography (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 magnetic resonance
imaging (MRI) scans.
This is an investigational study. Oxaliplatin is approved for treatment of colon and rectal
cancer but not approved in the US for use in the treatment of gastric cancer. Docetaxel and
5-FU are commonly used drugs for gastric cancer and are commercially available. 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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