Advanced CancersPhase 1NCT01213238
Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
A Phase 1 study testing Oxaliplatin, Capecitabine and Bevacizumab in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Oxaliplatin, Capecitabine and Bevacizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2010to 26 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 confirmed cancer with predominant liver metastases.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities).
- Adequate renal function (creatinine clearance >50 mL/min).
- Adequate liver function: total bilirubin </= 4 mg/dL, alanine transaminase (ALT) </= 5 times upper normal reference value. Patients with total bilirubin between 3.0 and 4.0 mg/dL must have blood ammonia level checked at baseline. Blood ammonia level must be within normal limits for enrollment.
- Adequate bone marrow function (absolute neutrophil count (ANC) >/= 1000 cells/uL; platelets (PLT) >/= 70,000 cells/uL).
- At least 3 weeks from prior cytotoxic chemotherapy or radiation therapy. If targeted or biologic therapy, there should be at least 5 half lives or 3 weeks, whichever is shorter, from day 1 of treatment.
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- All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test before the first dose, unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control.
- Ability and willingness to sign informed consent form.
- Must be >/= 18 years of age.
- Patients with unresectable liver-only (isolated liver) metastases are eligible; those who show adequate response may be considered for liver resection and/or radiofrequency ablation (RFA) of remaining disease.
Who cannot join
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients already in uncompensated liver failure (i.e., Child Pugh Liver Classification C).
- History of hypersensitivity to any component of the formulation.
- Exclusion criteria only for patients enrolled in Arm 1: Serious or non-healing wound, ulcer, or bone fracture.
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- Exclusion criteria only for patients enrolled in Arm 1: Any history of abdominal fistula or gastrointestinal perforation; or intra-abdominal abscess within 28 days of enrollment.
- Exclusion criteria only for patients enrolled in Arm 1: Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic Blood Pressure > 90 mm Hg).
- Exclusion criteria only for patients enrolled in Arm 1: History of bleeding CNS metastases.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Clinical Trial of Hepatic Arterial Infusion of Oxaliplatin, Oral Capecitabine, With or Without Systemic Bevacizumab for Patients With Advanced Cancer Metastatic to the Liver
The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.
Read the detailed description
The Study Drugs:
Oxaliplatin is designed to keep new cancer cells from growing.
Capecitabine is designed to interfere with the growth of cancer cells.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study "arm" based on the results of your screening tests. All patients will receive oxaliplatin and capecitabine. If your doctor thinks it is in your best interest, you will also receive bevacizumab.
- If you are in Arm 1, you will receive oxaliplatin, capecitabine, and bevacizumab.
- If you are in Arm 2, you will receive oxaliplatin and capecitabine.
Arm 1:
You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.
All participants will receive the same dose levels of oxaliplatin and bevacizumab.
Arm 2:
You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.
All participants will receive the same dose levels of oxaliplatin.
Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.
In each arm, after the highest tolerable dose of the study drug combination is found, up to 20 extra participants with any tumor type will receive that dose level.
Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.
Catheter Placement for Study Drug Administration:
You will be hospitalized to receive the study drug combination. On the day of your admission to the hospital, you will have a catheter (a sterile flexible tube that will be placed in the hepatic artery [a blood vessel in the liver] while you are under local anesthesia) through which you will receive the study drugs. The catheter will be placed and removed during each cycle. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
You must lay in bed for the entire time that the catheter is in place. The catheter will either be removed right after your chemotherapy or it may remain in overnight.
Study Drug Administration:
Arm 1:
After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You will then receive bevacizumab by vein over 1½ hours. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
On Days 1-14 of each cycle, you will take capecitabine by mouth 2 times each day. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.
Arm 2:
On Day 1 of each 21-day cycle, you will receive oxaliplatin through the catheter over 2 hours.
After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.
Study Visits:
At each study visit, you will be asked about any other drugs you may be taking and about any side effects you may be having.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn to test your blood's ability to clot.
- If you are able to become pregnant, you will have a urine pregnancy test.
At the end of every even cycle (Cycles 2, 4, 6, and so on):
- Blood (about 1 tablespoon) will be drawn to test for tumor markers.
- You will have scans to check the status of the disease. This may include a chest x-ray, CT scan, MRI scan, a PET scan, and/or a PET/CT scan. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug combination if the disease gets worse or intolerable side effects occur.
If the disease is only in your liver and you have responded to treatment, you may be eligible to receive surgery. If eligible, you will receive surgery 6 weeks after taking your last dose of study drugs if you are in Arm 1 or 4 weeks after taking your last dose of study drugs if you are in Arm 2. The study doctor will discuss this with you in more detail and you will sign a separate consent form if you have surgery.
Your participation on the study will be over once you have completed the follow-up visit.
Follow-Up Visit:
About 6 weeks after your last dose of study drugs, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will have a CT scan, MRI scan, PET scan, or PET/CT scan to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans may also be performed.
This is an investigational study. Oxaliplatin is FDA approved and commercially available for the treatment of colorectal cancer. Bevacizumab is FDA approved and commercially available for the treatment of colorectal and lung cancers. Capecitabine is FDA approved and commercially available for the treatment of colorectal and breast cancers.
Giving the study drugs together for advanced cancer is investigational.
Up to 116 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Oxaliplatin, Capecitabine, Bevacizumab
- Keywords
- Liver metastasis, hepatic arterial infusion, HAI, Eloxatin, Xeloda, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Oxaliplatin, Capecitabine, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Eloxatin
140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
CapecitabineDrug
Also called Xeloda
Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
10 mg/kg by vein on day 1 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin + Capecitabine + Bevacizumab | Experimental | Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle. Bevacizumab 10 mg/kg by vein on day 1 of a 21 day cycle. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab |
| Oxaliplatin + Capecitabine | Experimental | Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 -14 of a 21 day cycle. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Hepatic Arterial IUnfusion (HAI) Oxaliplatin, with Oral Capecitabine, with or without Systemic Intravenous Bevacizumab
If more than 33% of patients enrolled in any particular dose level develop dose limiting toxicity (DLT), treatment will continue at dose level immediately below. If not more than 33% of the patients in cohort develop DLT, this cohort considered MTD. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in current version of NCI CTCAE, even if related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome, but excluding alopecia; grade 4 thrombocytopenia; any grade 4 neutropenia of more than seven days duration, despite supportive care or associated with bleeding and/or sepsis; or any severe or life-threatening complication or abnormality not covered in NCI CTCAE. MTD defined by DLTs that occur in first cycle.
Measured: First 21 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study start30 Sep 2010
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apostolia M. Tsimberidou, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213238
- Sponsor's protocol ID
- 2010-0413
- Other IDs
- NCI-2012-01901
- Status last verified
- Mar 2019
- First submitted
- 30 Sep 2010
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Hepatic Arterial Infusion of Oxaliplatin, Oral Capecitabine, With or Without Systemic Bevacizumab for Patients With Advanced Cancer Metastatic to the Liver
- ClinicalTrials.gov ID
- NCT01213238
- Acronym / sponsor ID
- 2010-0413
- Conditions
- Advanced Cancers
- Keywords
- Liver metastasis, hepatic arterial infusion, HAI, Eloxatin, Xeloda, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.
Detailed description
The Study Drugs:
Oxaliplatin is designed to keep new cancer cells from growing.
Capecitabine is designed to interfere with the growth of cancer cells.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study "arm" based on the results of your screening tests. All patients will receive oxaliplatin and capecitabine. If your doctor thinks it is in your best interest, you will also receive bevacizumab.
- If you are in Arm 1, you will receive oxaliplatin, capecitabine, and bevacizumab.
- If you are in Arm 2, you will receive oxaliplatin and capecitabine.
Arm 1:
You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.
All participants will receive the same dose levels of oxaliplatin and bevacizumab.
Arm 2:
You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.
All participants will receive the same dose levels of oxaliplatin.
Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.
In each arm, after the highest tolerable dose of the study drug combination is found, up to 20 extra participants with any tumor type will receive that dose level.
Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.
Catheter Placement for Study Drug Administration:
You will be hospitalized to receive the study drug combination. On the day of your admission to the hospital, you will have a catheter (a sterile flexible tube that will be placed in the hepatic artery [a blood vessel in the liver] while you are under local anesthesia) through which you will receive the study drugs. The catheter will be placed and removed during each cycle. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
You must lay in bed for the entire time that the catheter is in place. The catheter will either be removed right after your chemotherapy or it may remain in overnight.
Study Drug Administration:
Arm 1:
After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You will then receive bevacizumab by vein over 1½ hours. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
On Days 1-14 of each cycle, you will take capecitabine by mouth 2 times each day. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.
Arm 2:
On Day 1 of each 21-day cycle, you will receive oxaliplatin through the catheter over 2 hours.
After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.
Study Visits:
At each study visit, you will be asked about any other drugs you may be taking and about any side effects you may be having.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn to test your blood's ability to clot.
- If you are able to become pregnant, you will have a urine pregnancy test.
At the end of every even cycle (Cycles 2, 4, 6, and so on):
- Blood (about 1 tablespoon) will be drawn to test for tumor markers.
- You will have scans to check the status of the disease. This may include a chest x-ray, CT scan, MRI scan, a PET scan, and/or a PET/CT scan. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug combination if the disease gets worse or intolerable side effects occur.
If the disease is only in your liver and you have responded to treatment, you may be eligible to receive surgery. If eligible, you will receive surgery 6 weeks after taking your last dose of study drugs if you are in Arm 1 or 4 weeks after taking your last dose of study drugs if you are in Arm 2. The study doctor will discuss this with you in more detail and you will sign a separate consent form if you have surgery.
Your participation on the study will be over once you have completed the follow-up visit.
Follow-Up Visit:
About 6 weeks after your last dose of study drugs, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will have a CT scan, MRI scan, PET scan, or PET/CT scan to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans may also be performed.
This is an investigational study. Oxaliplatin is FDA approved and commercially available for the treatment of colorectal cancer. Bevacizumab is FDA approved and commercially available for the treatment of colorectal and lung cancers. Capecitabine is FDA approved and commercially available for the treatment of colorectal and breast cancers.
Giving the study drugs together for advanced cancer is investigational.
Up to 116 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin + Capecitabine + Bevacizumab | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: BevacizumabOxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle. Bevacizumab 10 mg/kg by vein on day 1 of a 21 day cycle. |
| Oxaliplatin + Capecitabine | Experimental | Drug: Oxaliplatin, Drug: CapecitabineOxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 -14 of a 21 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically confirmed cancer with predominant liver metastases.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities).
- Adequate renal function (creatinine clearance >50 mL/min).
- Adequate liver function: total bilirubin </= 4 mg/dL, alanine transaminase (ALT) </= 5 times upper normal reference value. Patients with total bilirubin between 3.0 and 4.0 mg/dL must have blood ammonia level checked at baseline. Blood ammonia level must be within normal limits for enrollment.
- Adequate bone marrow function (absolute neutrophil count (ANC) >/= 1000 cells/uL; platelets (PLT) >/= 70,000 cells/uL).
Key exclusion criteria (9 listed)
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients already in uncompensated liver failure (i.e., Child Pugh Liver Classification C).
- History of hypersensitivity to any component of the formulation.
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 |
|---|---|---|
| OxaliplatinAlso: Eloxatin140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. | Drug | Oxaliplatin + Capecitabine, Oxaliplatin + Capecitabine + Bevacizumab |
| CapecitabineAlso: XelodaStarting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle. | Drug | Oxaliplatin + Capecitabine, Oxaliplatin + Capecitabine + Bevacizumab |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF10 mg/kg by vein on day 1 of a 21 day cycle. | Drug | Oxaliplatin + Capecitabine + Bevacizumab |
Primary outcome
Maximum Tolerated Dose (MTD) of Hepatic Arterial IUnfusion (HAI) Oxaliplatin, with Oral Capecitabine, with or without Systemic Intravenous Bevacizumab
Time frame: First 21 day cycle
If more than 33% of patients enrolled in any particular dose level develop dose limiting toxicity (DLT), treatment will continue at dose level immediately below. If not more than 33% of the patients in cohort develop DLT, this cohort considered MTD. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in current version of NCI CTCAE, even if related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome, but excluding alopecia; grade 4 thrombocytopenia; any grade 4 neutropenia of more than seven days duration, despite supportive care or associated with bleeding and/or sepsis; or any severe or life-threatening complication or abnormality not covered in NCI CTCAE. MTD defined by DLTs that occur in first cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- University of Texas 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.
Apostolia M. Tsimberidou, MD, PHD principal investigator
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 1 study testing Oxaliplatin, Capecitabine and Bevacizumab in people with Advanced Cancers, 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 10 inclusion and 9 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 15 Mar 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) of Hepatic Arterial IUnfusion (HAI) Oxaliplatin, with Oral Capecitabine, with or without Systemic Intravenous Bevacizumab (time frame: First 21 day cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2019.