Colorectal CancerPhase 1NCT02062749
Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma
A Phase 1 study testing Oxaliplatin in people with Colorectal Cancer, 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 tolerated dose of heated intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers also want to learn more about the ways that pediatric and young adult colon cancer may be different from colon cancer in adults. Read more about this study
- Who is it for?
- Ages 9 to 21 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2014to 27 Jun 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 9 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 9-21 years.
- Histologically proven colon carcinoma with serosal invasion or peritoneal disease or a history of tumor rupture, and/or ascites
- Radiologic workup must demonstrate that the disease is confined to the abdominal cavity and/or is controlled outside of the abdominal cavity.
- Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness
- Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist
- Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, pregnant or lactating females.
Show all 11Show fewer
- Patients must have fully intact mental status and normal neurologic abilities. Intact mental status is defined by 'the capacity to identify and recall one's identity and place in time and space. Assessment of mental status and documentation of fully intact mental status will be completed using physical and mental exam by the referring doctor or oncologist.
- Patients must have Adequate Renal Function Defined as: Creatinine clearance or radioisotope GFR >/=70ml/min/1.73 m^2 or a serum creatinine based on age/gender less than listed value in the table below: 1 to < 2 years 0.6 mg/dL for both males and females, 2 to < 6 years 0.8 mg/dL for both males and females, 6 to < 10 years 1 mg/dL for both males and females, 10 to < 13 years 1.2 mg/dL for both males and females, 13 to < 16 years 1.5 mg/dL for males and 1.4 mg/dL for females, >/= 16 years 1.7 for males and 1.4 for females
- Patients will be eligible if the WBC is >/=2000/µl or ANC is >/=1,500 and platelets are >/= 100,000/mm3
- Patients will be eligible if serum total bilirubin and liver enzymes are </= 2 times the upper limit of normal
- Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment
Who cannot join
- Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
- Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
- Patients who have failed previous intraperitoneal platinum therapy will be ineligible ("Failed" is having disease recurrence </= 3 months.)
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 Trial With Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma
The goal of this clinical research study is to find the highest tolerated dose of heated intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers also want to learn more about the ways that pediatric and young adult colon cancer may be different from colon cancer in adults.
Read the detailed description
Surgery and Study Drug Administration:
If you are found to be eligible to take part in this study, abdominal surgery will be performed to try to remove as many tumors as possible. The abdominal surgery is not being performed specifically for this research study and would be performed even if you did not take part in this study. You will be given a separate consent form to sign that explains the details and risks of surgery in more detail.
During surgery, the abdomen will be temporarily closed. Then the abdominal wash will begin. During the "abdominal wash," heated oxaliplatin will be delivered through plastic tubing that is connected to a pump into the abdomen. The pump pushes the heated oxaliplatin into the abdomen and then pulls it out and recirculates the oxaliplatin. The skin of the abdomen is temporarily closed during the abdominal wash. The surgeon will also "wash" over the closed area of the surgical site. A pump will be used to pump heated oxaliplatin in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the oxaliplatin reaches all areas in the abdomen. After 90 minutes, the oxaliplatin is removed and the abdomen will be "washed" with saline and all fluid will be removed before the surgeon permanently closes the abdomen with 3 layers of stitches.
Two (2) pea-sized tissue samples (tumor and normal abdominal tissue), 2 tablespoons of blood will be sent to the laboratory of Dr. Scott Kopetz for tissue evaluation and extraction of RNA (genetic material). One (1) tumor sample will be removed before the procedure and the other sample will be removed at the end of the procedure. The samples will be examined under a microscope and DNA (the genetic material in cells) will be removed to look for any changes to the DNA. The results of these tests will not be shared with you, nor will they be used for any decisions regarding your treatment.
There is a chance that the surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, your doctor will discuss other treatment options with you.
Study Visits:
On Day 1 after surgery:
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will have a physical exam.
On Days 2-5, 11, 14, and 30 after surgery:
- Blood (about 1-3 teaspoons) will be drawn for routine tests.
- You will have a physical exam.
- On Day 30 only, you will have a hearing test.
If the doctor thinks it is needed, you will also have follow up visits at 3 and 6 months after surgery. If these visits occur here at MD Anderson, you will not have a hearing test, but you will have an MRI, CT, or PET-CT scan to check the status of the disease. The 3 and 6 month visits following surgery may be performed at your local doctor's office and/or laboratory.
Length of Study:
You will remain on study for up to 6 months. You will be taken off study if the disease gets worse.
If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, you may be eligible for a re-perfusion, which is a repeat of the surgery and study drug administration. If you are eligible for a re-perfusion, your participation on this study will end and you will be given a new consent form to sign in order to be re-enrolled back onto this study.
This is an investigational study. Oxaliplatin is FDA approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of heated oxaliplatin given intra-abdominally in pediatric patients with colon cancer is investigational. The study doctor can explain how the study drug is designed to work.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Colorectal Cancer
- Being tested
- Oxaliplatin
- Keywords
- Colorectal cancer, Colon Cancer, Pediatric, Adolescent, Hyperthermic Intraperitoneal Chemotherapy, HIPEC, Oxaliplatin, Eloxatin
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Eloxatin
Starting dose of Oxaliplatin is 175 mg/m2 delivered by hyperthermic intraperitoneal chemotherapy over 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy | Experimental | After cytoreductive surgery and lysis of adhesions, two large bore catheters are placed in the peritoneal cavity through the incision. Thirty minutes before HIPEC is begun, body temperature is cooled to 35°C. ). The catheters are connected to a perfusion circuit. Heated Oxaliplatin is added to the perfusate administered over 90 minutes. The starting dose of Oxaliplatin is 175 mg/m2. Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerate Dose (MTD) of Oxaliplatin in Hyperthermic Intraperitoneal Chemotherapy
MTD is highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT). DLT may occur at any time during the initial hospitalization before discharge following the hyperthermic intraperitoneal chemotherapy (HITC). DLT defined in two ways: Hematologic DLT defined as Grade IV neutropenia, anemia, or thrombocytopenia; and Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within two weeks of the HITC, or before hospital discharge, or Grade III fever occurring after the HITC.
Measured: 3 months
Secondary outcomes (1)
Differences in Genetic Aberrations in Pediatric Colon Cancer Patients and Adult Patients
Descriptive statistics on genetic aberrations provided, either by tabulations of frequencies or summary statistics including numbers, mean, standard deviation, median, minimum and maximum, when appropriate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study start19 May 2014
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Hayes-Jordan, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062749
- Sponsor's protocol ID
- 2013-0438
- Other IDs
- NCI-2014-01239
- Status last verified
- Jul 2018
- First submitted
- 11 Feb 2014
- Last updated
- 19 Jul 2018
- 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 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial With Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma
- ClinicalTrials.gov ID
- NCT02062749
- Acronym / sponsor ID
- 2013-0438
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Colon Cancer, Pediatric, Adolescent, Hyperthermic Intraperitoneal Chemotherapy, HIPEC, Oxaliplatin, Eloxatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 May 2014 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 14 Feb 2014 (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 tolerated dose of heated intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers also want to learn more about the ways that pediatric and young adult colon cancer may be different from colon cancer in adults.
Detailed description
Surgery and Study Drug Administration:
If you are found to be eligible to take part in this study, abdominal surgery will be performed to try to remove as many tumors as possible. The abdominal surgery is not being performed specifically for this research study and would be performed even if you did not take part in this study. You will be given a separate consent form to sign that explains the details and risks of surgery in more detail.
During surgery, the abdomen will be temporarily closed. Then the abdominal wash will begin. During the "abdominal wash," heated oxaliplatin will be delivered through plastic tubing that is connected to a pump into the abdomen. The pump pushes the heated oxaliplatin into the abdomen and then pulls it out and recirculates the oxaliplatin. The skin of the abdomen is temporarily closed during the abdominal wash. The surgeon will also "wash" over the closed area of the surgical site. A pump will be used to pump heated oxaliplatin in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the oxaliplatin reaches all areas in the abdomen. After 90 minutes, the oxaliplatin is removed and the abdomen will be "washed" with saline and all fluid will be removed before the surgeon permanently closes the abdomen with 3 layers of stitches.
Two (2) pea-sized tissue samples (tumor and normal abdominal tissue), 2 tablespoons of blood will be sent to the laboratory of Dr. Scott Kopetz for tissue evaluation and extraction of RNA (genetic material). One (1) tumor sample will be removed before the procedure and the other sample will be removed at the end of the procedure. The samples will be examined under a microscope and DNA (the genetic material in cells) will be removed to look for any changes to the DNA. The results of these tests will not be shared with you, nor will they be used for any decisions regarding your treatment.
There is a chance that the surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, your doctor will discuss other treatment options with you.
Study Visits:
On Day 1 after surgery:
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will have a physical exam.
On Days 2-5, 11, 14, and 30 after surgery:
- Blood (about 1-3 teaspoons) will be drawn for routine tests.
- You will have a physical exam.
- On Day 30 only, you will have a hearing test.
If the doctor thinks it is needed, you will also have follow up visits at 3 and 6 months after surgery. If these visits occur here at MD Anderson, you will not have a hearing test, but you will have an MRI, CT, or PET-CT scan to check the status of the disease. The 3 and 6 month visits following surgery may be performed at your local doctor's office and/or laboratory.
Length of Study:
You will remain on study for up to 6 months. You will be taken off study if the disease gets worse.
If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, you may be eligible for a re-perfusion, which is a repeat of the surgery and study drug administration. If you are eligible for a re-perfusion, your participation on this study will end and you will be given a new consent form to sign in order to be re-enrolled back onto this study.
This is an investigational study. Oxaliplatin is FDA approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of heated oxaliplatin given intra-abdominally in pediatric patients with colon cancer is investigational. The study doctor can explain how the study drug is designed to work.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy | Experimental | Drug: OxaliplatinAfter cytoreductive surgery and lysis of adhesions, two large bore catheters are placed in the peritoneal cavity through the incision. Thirty minutes before HIPEC is begun, body temperature is cooled to 35°C. ). The catheters are connected to a perfusion circuit. Heated Oxaliplatin is added to the perfusate administered over 90 minutes. The starting dose of Oxaliplatin is 175 mg/m2. |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age 9-21 years.
- Histologically proven colon carcinoma with serosal invasion or peritoneal disease or a history of tumor rupture, and/or ascites
- Radiologic workup must demonstrate that the disease is confined to the abdominal cavity and/or is controlled outside of the abdominal cavity.
- Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness
- Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist
Key exclusion criteria (4 listed)
- Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
- Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
- Patients who have failed previous intraperitoneal platinum therapy will be ineligible ("Failed" is having disease recurrence </= 3 months.)
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: EloxatinStarting dose of Oxaliplatin is 175 mg/m2 delivered by hyperthermic intraperitoneal chemotherapy over 90 minutes. | Drug | Hyperthermic Intraperitoneal Chemotherapy |
Primary outcome
Maximum Tolerate Dose (MTD) of Oxaliplatin in Hyperthermic Intraperitoneal Chemotherapy
Time frame: 3 months
MTD is highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT). DLT may occur at any time during the initial hospitalization before discharge following the hyperthermic intraperitoneal chemotherapy (HITC). DLT defined in two ways: Hematologic DLT defined as Grade IV neutropenia, anemia, or thrombocytopenia; and Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within two weeks of the HITC, or before hospital discharge, or Grade III fever occurring after the HITC.
1 secondary outcome
Differences in Genetic Aberrations in Pediatric Colon Cancer Patients and Adult Patients
Time frame: 6 months
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 19 Jul 2018.
- 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.
Andrea Hayes-Jordan, MD 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 in people with Colorectal 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 11 inclusion and 4 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 19 Jul 2018. 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 Tolerate Dose (MTD) of Oxaliplatin in Hyperthermic Intraperitoneal Chemotherapy (time frame: 3 months). 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 19 Jul 2018.