NCT02062749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1 colorectal-cancer

Timeline
Completed

Started May 2014

Typical duration for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 19, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

4.1 years

First QC Date

February 11, 2014

Last Update Submit

July 17, 2018

Conditions

Colorectal Cancer

Keywords

Colorectal cancerColon CancerPediatricAdolescentHyperthermic Intraperitoneal ChemotherapyHIPECOxaliplatinEloxatin

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Differences in Genetic Aberrations in Pediatric Colon Cancer Patients and Adult Patients

    6 months

Other Outcomes (1)

  • Time to Recurrence After HIPEC in Pediatric, Adolescent and Young Adult Age Colon Cancer Patients

    6 months

Study Arms (1)

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.

Drug: Oxaliplatin

Interventions

OxaliplatinDRUG

Starting dose of Oxaliplatin is 175 mg/m2 delivered by hyperthermic intraperitoneal chemotherapy over 90 minutes.

Also known as: Eloxatin
Hyperthermic Intraperitoneal Chemotherapy

Eligibility Criteria

Age9 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Andrea Hayes-Jordan, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 14, 2014

Study Start

May 19, 2014

Primary Completion

June 27, 2018

Study Completion

June 27, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

US(1)