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A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater

Phase 2
18 Years
Not Enrolling
Gastrointestinal Cancer

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Trial Information

A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater

Oxaliplatin is a chemotherapy drug designed to destroy cancer cells by interfering with DNA
function, which is necessary for growth of new cells.

Capecitabine is a chemotherapy drug designed to destroy cancer cells by interfering with
cell division, which is important to the growth of cancer.

You will receive 14 days of treatment followed by 7 days without treatment, 21 days in all,
otherwise known as a "cycle" of therapy. On Day 1 of each cycle, you will receive
oxaliplatin injected into a vein over a period of 2 hours. For this injection, you will need
to have a small tube inserted into a vein under the skin of the chest (central venous line)
to receive oxaliplatin. Oxaliplatin must be given at M.D. Anderson.

You will take capecitabine tablets twice a day for the first two weeks (Days 1-14) of each
3-week cycle. No treatment will be given for the next 7 days. You must take capecitabine
within 30 minutes after breakfast and dinner, with morning and evening doses about 12 hours
apart. You should take capecitabine by mouth with water, and not fruit juices. At the
first treatment visit and every 3 weeks, you will receive enough capecitabine to last until
the next visit. At each visit, you must return any capecitabine you have not used as well as
all empty bottles.

During Cycle 1, routine blood tests (about 2 teaspoons of blood) will be done once a week.
Before each new cycle of therapy, you will have a complete physical exam and blood (about 2
½ teaspoons) will be collected for routine tests. You will be asked by the study doctor
about all medications you have taken since starting the study drugs and any health problems
that you may have experienced. Also, you will have an x-ray or computed tomography (CT)
scan of the chest and either CT scans or magnetic resonance imaging (MRIs) of the tumor(s)
every 3 cycles and at the end of the study. Additional tests may be done during the study if
your doctor feels it is necessary for your care.

This study will require you to receive at least 3 cycles of treatment. However, if you
experience severe side effects or your disease becomes worse, treatment may be delayed,
stopped, or you may receive smaller doses of the treatment. You may continue to receive
treatment on this study until the disease gets worse or you experience any intolerable side
effects. If this happens, you will be taken off the study and your doctor will discuss
other treatment options with you.

When you stop taking part in the study, you will have blood (about 3 teaspoons) collected
for routine tests. You will have a physical exam and either a CT scan or an MRI to check on
the status of the disease. You will be contacted by phone every three months for the rest
of your life to check on your state of health and ask you about further symptoms you may be

This is an investigational study. The drugs oxaliplatin and capecitabine are FDA approved
for treatment of advanced cancer of the colon or rectum. The drugs are not approved for
small bowel or ampulla of Vater cancer. Their use together in this study is investigational.
Up to 30 people will take part in this study. All will be enrolled at M.D. Anderson.

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed adenocarcinoma of the
small bowel or ampulla of Vater that is either unresectable or metastatic.

2. Patients must have measurable disease as per the modified Response Evaluation
Criteria In Solid Tumors (RECIST) criteria.

3. Patients may be previously untreated or have received previous systemic therapy,
limited to 5-FU/leucovorin or capecitabine, as adjuvant or neoadjuvant therapy or as
a radiosensitizer. Patients may have received capecitabine or 5-FU administered as a
radiosensitizing agent concurrently with external beam radiotherapy as preoperative
or postoperative therapy. Patients may have received capecitabine or 5-FU/leucovorin
as part of adjuvant chemotherapy.

4. If radiation was previously received, the measurable disease must be outside the
previous radiation field.

5. A minimum of 4 weeks must have elapsed since completion of any prior chemotherapy or
radiotherapy. A minimum of 4 weeks must have elapsed since any prior surgery.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to

7. Adequate bone marrow function defined as absolute peripheral granulocyte count of
greater than or equal to 1500 mm3, platelet count greater than or equal to 1500 mm3,
and hemoglobin greater than or equal to 10 gm/dL.

8. Adequate renal function, defined as serum creatinine less than or equal to 1.5 * ULN
and calculated creatinine clearance >30 mL/min.

9. Patients must have adequate hepatic function: total bilirubin less than or equal to
1.5 gm/dL; serum albumin greater than or equal to 2.5 gm/dL. If the patient does not
have liver metastasis, transaminases may be up to 2 * the ULN. If the patient has
liver metastasis, transaminases up to 5 * Upper Limit of Normal (ULN) are allowed.

10. Negative urine or serum pregnancy test in women with childbearing potential, within
one week prior to initiation of treatment.

11. The effects of the combination of oxaliplatin and capecitabine on the developing
fetus are unknown. For this reason, women of childbearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control)
prior to study entry and for the duration of study participation. Should a woman
become pregnant while participating in this study, she should inform her treating
physician immediately.

12. Patients must sign an Informed Consent and Authorization indicating that they are
aware of the investigational nature of this study and the known risks involved.

13. Age greater than or equal to 18 years. Because no dosing or adverse event data are
currently available on the use of XELOX in patients <18 years of age, children are
excluded from this study.

14. Patients taking therapeutic doses of coumarin-derivative anticoagulants should be
switched to low-molecular-weight heparin (LMWH). Low-dose Coumadin (e.g. 1 mg by
mouth (PO) per day) in patients with in-dwelling venous access devices is allowed.

Exclusion Criteria:

1. Patients with prior exposure to platinum therapy are excluded. Patients who have
received prior chemotherapy for metastatic disease are excluded.

2. Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or
Mitomycin C) prior to entering the study or those who have not recovered from adverse
events due to agents administered more than 4 weeks earlier.

3. Patients may not be receiving any other investigational agents nor have received any
investigational drug 30 days prior to enrollment.

4. Patients with known brain metastases are excluded from this clinical trial because of
their poor prognosis and their risk for progressive neurologic dysfunction that would
confound the evaluation of neurologic and other adverse events.

5. Gastrointestinal tract disease resulting in an inability to take oral medication or a
requirement for IV alimentation. Prior surgical therapy affecting absorption.

6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

7. Because patients with immune deficiency are at increased risk of lethal infections
when treated with marrow-suppressive therapy, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with XELOX. Appropriate studies will be undertaken in
patients receiving combination anti-retroviral therapy when indicated.

8. Patients with extensive symptomatic fibrosis of the lungs.

9. Peripheral neuropathy > grade 1.

10. Known Dihydropyrimidine dehydrogenase deficiency (DPD deficiency)

11. Patients receiving therapeutic doses of coumarin-derivative anticoagulant therapy are
excluded since a drug interaction between capecitabine and coumarin anticoagulants
has been reported. Patients requiring anticoagulation who may be safely switched to
LMWH are eligible.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Overall Response

Outcome Description:

Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.

Outcome Time Frame:

Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses

Safety Issue:


Principal Investigator

Robert A. Wolff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2004

Completion Date:

November 2009

Related Keywords:

  • Gastrointestinal Cancer
  • Gastrointestinal Cancer
  • Small Bowel Cancer
  • Ampulla of Vater
  • Capecitabine
  • Xeloda
  • Oxaliplatin
  • Eloxatin
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Gastrointestinal Neoplasms



U.T. M.D. Anderson Cancer Center Houston, Texas  77030