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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 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Diseases

Thank you

Trial Information

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


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.


Inclusion Criteria:



1. Histologically documented adenocarcinoma of the stomach or Gastroesophageal Junction
(GEJ).

2. Age >18 years;

3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;

4. Chemotherapy: No prior chemotherapy is permitted for metastatic disease. Use of prior
chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a
radiosensitization is permitted, provided that the minimum time from completion of
such treatment to study entry is at least 12 months;

5. Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of
bone marrow reserve provided that they have recovered from the acute, toxic effects
of radiotherapy prior to registration. A minimum of 14 days must have elapsed since
the end of radiotherapy.

6. Previous Surgery: Previous surgery is permitted provided that wound healing has
occurred prior to registration. Minimum of 14 days must have elapsed between a major
surgery and start of chemotherapy.

7. At least one target lesion >20 mm (or >10 mm on spiral CT-scan). If indicator lesions
are in a previously irradiated field, only a clear disease progression of the
irradiated lesion or a new lesion in the previously irradiated field will be accepted

8. Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Neutrophils >1.5 * 10*9/L and platelets >100 * 10*9/L; Bilirubin <1.5 * upper limit
of the normal range (ULN); aspartate aminotransferase (AST or SGOT) and/or alanine
aminotransferase (ALT or SGPT) <2.5 * ULN; Serum creatinine <1.5 * ULN;

9. Patients must give written informed consent to participate in the study.

10. Patients - both males and females - with reproductive potential (ie, menopausal for
less than 1 year and not surgically sterilized) must practice effective contraceptive
measures throughout the study. Women of child-bearing potential must have a negative
pregnancy test (serum or urine) within 14 days prior to registration.

Exclusion Criteria:

1. Concurrent anticancer therapy

2. Pregnant or lactating women

3. History of other prior malignancy except for adequately treated basal cell or
squamous cell skin cancer; in situ cervical cancer or malignancy from which the
patient has been disease-free for 5 years;

4. Brain metastases

5. Patients with active or uncontrolled infections or with serious illnesses or medical
conditions, including patients with a history of chronic alcohol abuse, hepatitis,
HIV and/or cirrhosis

6. History of any psychiatric condition that might impair the patient's ability to
understand or to comply with the requirements of the study or to provide informed
consent.

7. Known hypersensitivity to any of the drugs.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Description:

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 D-FOX (One cycle = 28 days).

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Jaffer Ajani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2004-0290

NCT ID:

NCT00526110

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Gastrointestinal Diseases
  • Gastrointestinal Diseases
  • Adenocarcinoma of the Stomach
  • Gastroesophageal Junction Cancer
  • Cancer of the Stomach
  • 5-Fluorouracil
  • 5-FU
  • Adrucil
  • Efudex
  • Docetaxel
  • Oxaliplatin
  • Eloxatin
  • Taxotere
  • Esophagus
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Gastrointestinal Diseases
  • Digestive System Diseases
  • Stomach Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030