Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer

Temple University Health System (TUHS)

Status and phase

Terminated

Phase 1

Conditions

Stage IV Rectal Cancer

Recurrent Colon Cancer

Signet Ring Adenocarcinoma of the Colon

Mucinous Adenocarcinoma of the Rectum

Stage IV Colon Cancer

Signet Ring Adenocarcinoma of the Rectum

Mucinous Adenocarcinoma of the Colon

Liver Metastases

Recurrent Rectal Cancer

Treatments

Procedure: hepatic artery embolization

Combination Product: irinotecan-eluting beads

Study type

Interventional

Funder types

Other

Identifiers

NCT01285102

GI-063 (Other Identifier)

10-002

NCI-2010-01114

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking blood flow to the tumor and keeping chemotherapy drugs near the tumor.

PURPOSE: This phase II trial is studying how well chemoembolization using irinotecan works in treating patients with liver metastases from metastatic colon or rectal cancer.

Full description

PRIMARY OBJECTIVES:

I. To define the response rate of colorectal liver metastases (in the treated lobe) treated with DEBIRI, in refractory mCRC patients.

SECONDARY OBJECTIVES:

I. To evaluate the time to progression in the treated lobe for this patient population.

II. To evaluate the overall survival for this patient population. III. To evaluate patient tolerance and the toxicity profile of treatment with DEBIRI in this patient population.

OUTLINE:

Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and for which standard curative measures do not exist
Patients must have received prior irinotecan-based treatment for their disease and had documented progression by RECIST criteria; patients must also have received prior fluoropyrimidine and oxaliplatin-based therapy
Liver disease must not be amenable to potentially curative surgical resection
Patients must have liver-only or liver-predominant disease to be eligible for this study; hepatic disease must be dominant, but patients are allowed to have extrahepatic disease provided it is not judged likely to be life threatening within 3 months
Patients must have a patent portal vein as documented by CT, MRI, or ultrasound
Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to study entry; patients with history of prior radiation to the liver including radio-labeled microspheres cannot take part in this study
Eastern Cooperative Oncology Group performance status 0-1
Previous surgery or RFA to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
Life expectancy of >= 12 weeks
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin =< ULN
AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase =< 2.5 X institutional ULN
Creatinine < 2.0 mg/dL
PT/PTT < 1.5 X ULN
Women of childbearing potential (WOCBP) and sexually active males must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential
Patients must demonstrate ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Patients who have had chemotherapy (including targeted therapy i.e. cetuximab, panitumumab) or radiotherapy =< 4 weeks or treatment with bevacizumab =< 6 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 4 weeks earlier, with the exclusion of alopecia or neuropathy; patient with history of radiation to the liver including radio-labeled microspheres at any point in their past will be excluded
Patients may not be receiving nor have received any other investigational agent =< 4 weeks prior to study registration
Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including death from the therapeutic agents
Patients with known brain metastases are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events
As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known hepatitis B or C are excluded from the study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible
Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin
Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
Patients with previous chemoembolization to liver metastases
Patients may not receive any other anticancer therapy while on study, including immunotherapy; patients may not receive any other clinical investigational drug