Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients
Phase I Objectives
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).
1. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination.
Phase II Objectives
1. To assess time to cancer progression to D-FOX treatment regimen.
- To assess response rate to D-FOX treatment regimen.
- To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination treatment regimen.
- Determine overall survival.
- Perform an exploratory investigation into the effect of D-FOX on phenotypic abnormalities in blood.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]MTD is the highest dose at which 1 or fewer dose limiting toxicities (DLT's) are observed in 6 patients. DLT defined as any non-hematologic grade III/IV or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy. Response evaluated after two 14-day treatments of Docetaxel, 5-Fluorouracil and Oxaliplatin (One cycle = 28 days).
- Progression Free Survival [ Time Frame: Assessed from baseline to 30 months ] [ Designated as safety issue: No ]Progression Free Survival (PFS) defined as the time from the first study drug administration until the first day of radiological and/or symptomatic disease progression is documented, or the start of further anticancer therapy or death from any cause, whichever occurs first. Kaplan-Meier curve was used to estimate PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.
- Median Overall Survival [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]Overall survival was defined as the time from the start of treatment until death or last follow-up. Kaplan-Meier curve was used to estimate overall survival.
|Study Start Date:||August 2004|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: 5-Fluorouracil + Docetaxel + Oxaliplatin
5-Fluorouracil 2.2 Gm/m^2 intravenously (IV) over 48 hours on Day 1. Docetaxel 20 mg/m^2 IV over 60 minutes. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1.
2.2 Gm/m^2 IV over 48 hours on Day 1.
Other Names:Drug: Docetaxel
20 mg/m^2 IV over 60 minutes
Other Name: TaxotereDrug: Oxaliplatin
85 mg/m^2 IV over 120 minutes on Day 1.
Other Name: Eloxatin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526110
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jaffer Ajani, MD||M.D. Anderson Cancer Center|