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Trial record 9 of 1980 for:    oxaliplatin

Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma

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ClinicalTrials.gov Identifier: NCT02062749
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Oxaliplatin Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial With Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma
Actual Study Start Date : May 19, 2014
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Hyperthermic Intraperitoneal Chemotherapy
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.
Drug: Oxaliplatin
Starting dose of Oxaliplatin is 175 mg/m2 delivered by hyperthermic intraperitoneal chemotherapy over 90 minutes.
Other Name: Eloxatin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Differences in Genetic Aberrations in Pediatric Colon Cancer Patients and Adult Patients [ Time Frame: 6 months ]
    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.


Other Outcome Measures:
  1. Time to Recurrence After HIPEC in Pediatric, Adolescent and Young Adult Age Colon Cancer Patients [ Time Frame: 6 months ]
    Time to recurrence defined as time from treatment to recurrence (event) or to last follow-up date (censored), using the Kaplan-Meier method, with 95% confidence interval. Evaluation of measurable disease by CT or MRI and physical exam.



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Ages Eligible for Study:   9 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 9-21 years.
  2. Histologically proven colon carcinoma with serosal invasion or peritoneal disease or a history of tumor rupture, and/or ascites
  3. Radiologic workup must demonstrate that the disease is confined to the abdominal cavity and/or is controlled outside of the abdominal cavity.
  4. 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
  5. 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
  6. 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.
  7. 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.
  8. 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
  9. Patients will be eligible if the WBC is >/=2000/µl or ANC is >/=1,500 and platelets are >/= 100,000/mm3
  10. Patients will be eligible if serum total bilirubin and liver enzymes are </= 2 times the upper limit of normal
  11. 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

Exclusion Criteria:

  1. Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
  2. Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled
  3. Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
  4. Patients who have failed previous intraperitoneal platinum therapy will be ineligible ("Failed" is having disease recurrence </= 3 months.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062749


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Andrea Hayes-Jordan, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02062749     History of Changes
Other Study ID Numbers: 2013-0438
NCI-2014-01239 ( Registry Identifier: NCI CTRP )
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Colorectal cancer
Colon Cancer
Pediatric
Adolescent
Hyperthermic Intraperitoneal Chemotherapy
HIPEC
Oxaliplatin
Eloxatin
Additional relevant MeSH terms:
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Oxaliplatin
Colorectal Neoplasms
Fever
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Body Temperature Changes
Signs and Symptoms
Antineoplastic Agents