Gastrointestinal CancerPhase 2NCT00354887
Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater
A Phase 2 study testing Capecitabine and Oxaliplatin in people with Gastrointestinal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of the small bowel or ampulla of Vater that is either unresectable or metastatic.
- Patients must have measurable disease as per the modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- 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.
- If radiation was previously received, the measurable disease must be outside the previous radiation field.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.
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- 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.
- Adequate renal function, defined as serum creatinine less than or equal to 1.5 * ULN and calculated creatinine clearance >30 mL/min.
- 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.
- Negative urine or serum pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
- 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.
- 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.
- 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.
- 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.
Who cannot join
- Patients with prior exposure to platinum therapy are excluded. Patients who have received prior chemotherapy for metastatic disease are excluded.
- 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.
- Patients may not be receiving any other investigational agents nor have received any investigational drug 30 days prior to enrollment.
- 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.
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation. Prior surgical therapy affecting absorption.
- 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.
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- 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.
- Patients with extensive symptomatic fibrosis of the lungs.
- Peripheral neuropathy > grade 1.
- Known Dihydropyrimidine dehydrogenase deficiency (DPD deficiency)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater
Primary Objective:
- To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater.
Secondary objectives include determining the toxicity, time-to-treatment failure, and overall survival rates in patients treated with this combination.
Read the detailed description
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 experiencing.
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.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Capecitabine, Oxaliplatin
- Keywords
- Gastrointestinal Cancer, Small Bowel Cancer, Ampulla of Vater, Capecitabine, Xeloda, Oxaliplatin, Eloxatin
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Oral capecitabine 750 mg/m^2 twice daily (total daily dose 1500 mg/m^2) on Days 1-14 in 21 Day Cycle.
OxaliplatinDrug
Also called Eloxatin
130 mg/m^2 by vein Day 1 over 2 hours in 21 Day Cycle
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin + Capecitabine | Experimental | Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14. Receives: Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Overall Response
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.
Measured: Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startNov 2004
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Sponsor
- Investigators
- Robert A. Wolff, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354887
- Sponsor's protocol ID
- 2003-0827
- Status last verified
- Oct 2012
- First submitted
- 18 Jul 2006
- Last updated
- 29 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Overman MJ, Varadhachary GR, Kopetz S, Adinin R, Lin E, Morris JS, Eng C, Abbruzzese JL, Wolff RA. Phase II study of capecitabine and oxaliplatin for advanced adenocarcinoma of the small bowel and ampulla of Vater. J Clin Oncol. 2009 Jun 1;27(16):2598-603. doi: 10.1200/JCO.2008.19.7145. Epub 2009 Jan 21.
PubMed 19164203
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater
- ClinicalTrials.gov ID
- NCT00354887
- Acronym / sponsor ID
- 2003-0827
- Conditions
- Gastrointestinal Cancer
- Keywords
- Gastrointestinal Cancer, Small Bowel Cancer, Ampulla of Vater, Capecitabine, Xeloda, Oxaliplatin, Eloxatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Nov 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Posted 14 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater.
Secondary objectives include determining the toxicity, time-to-treatment failure, and overall survival rates in patients treated with this combination.
Detailed description
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 experiencing.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin + Capecitabine | Experimental | Drug: Capecitabine, Drug: OxaliplatinIntravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the small bowel or ampulla of Vater that is either unresectable or metastatic.
- Patients must have measurable disease as per the modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- 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.
- If radiation was previously received, the measurable disease must be outside the previous radiation field.
- 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.
Key exclusion criteria (11 listed)
- Patients with prior exposure to platinum therapy are excluded. Patients who have received prior chemotherapy for metastatic disease are excluded.
- 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.
- Patients may not be receiving any other investigational agents nor have received any investigational drug 30 days prior to enrollment.
- 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.
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation. Prior surgical therapy affecting absorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XelodaOral capecitabine 750 mg/m^2 twice daily (total daily dose 1500 mg/m^2) on Days 1-14 in 21 Day Cycle. | Drug | Oxaliplatin + Capecitabine |
| OxaliplatinAlso: Eloxatin130 mg/m^2 by vein Day 1 over 2 hours in 21 Day Cycle | Drug | Oxaliplatin + Capecitabine |
Primary outcome
Number of Participants With Overall Response
Time frame: Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19164203Overman MJ, Varadhachary GR, Kopetz S, Adinin R, Lin E, Morris JS, Eng C, Abbruzzese JL, Wolff RA. Phase II study of capecitabine and oxaliplatin for advanced adenocarcinoma of the small bowel and ampulla of Vater. J Clin Oncol. 2009 Jun 1;27(16):2598-603. doi: 10.1200/JCO.2008.19.7145. Epub 2009 Jan 21.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A. Wolff, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Oxaliplatin in people with Gastrointestinal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Overall Response (time frame: Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00354887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.