Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

NCT00059930 | Completed Phase 1

• 2 other identifiers: 03-005MSKCC-03005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to find the highest dose that can be given safely to people who have had liver disease resected. This is a Phase I study. The goal of a phase I study is to find a safe dose range based on side effects. The drugs that will be given by vein are OXALIPLATIN ("Oxali") plus 5-FLUOROURACIL and LEUCOVORIN ("5FU" and "LV"). This is systemic chemotherapy, since it goes to the whole body. The drugs that will be placed in the pump are FLOXURIDINE (FUDR) and DEXAMETHASONE. (The dexamethasone is not an anti-tumor drug; it helps protect healthy liver tissue from possible side effects of the FUDR.) This is the regional chemotherapy, since it goes only to the liver. The researchers have studied these drugs and know the best doses of each when they are used in patients who have not had liver resections. We do not yet know how the drugs work with each other in patients with a liver resection. This study will tell us the best doses of each drug when they are given over the same period of time.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

liver metastases; stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  2 years

• Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue

  2 years

Study Arms (1)

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

EXPERIMENTAL

This is a Phase I study with the primary objective of defining the maximum tolerated dose of hepatic arterial floxuridine (FUDR) and dexamethasone (Dex) given via an implanted pump in combination with intravenous oxaliplatin plus systemic fluorouracil (5FU)/leucovorin (LV) in the adjuvant setting after resection of hepatic metastases from colorectal cancer. A total of eleven dose levels will be considered.

Drug: FOLFOX regimen; Drug: dexamethasone; Drug: floxuridine; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: conventional surgery

Interventions

FOLFOX regimen DRUG

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

dexamethasone DRUG

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

floxuridine DRUG

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

fluorouracil DRUG

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

leucovorin calcium DRUG

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

oxaliplatin DRUG

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

adjuvant therapy PROCEDURE

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

conventional surgery PROCEDURE

Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Confirmation of diagnosis must be performed at MSKCC.
• Potentially completely resectable hepatic metastases without current evidence of other metastatic disease.
• Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to registration. (MRI of abdomen may be substituted for CT of abdomen.)
• Lab values within 14 days prior to registration:
• WBC ≥ 3.0 K/ul
• ANC \>1.5 K/ul
• Platelets ≥ 100 K/ul
• Total bilirubin ≤ 1.5 mg/dl.
• Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study.
• KPS ≥ 60%
• Signed informed consent.

You may not qualify if:

• Prior radiation to the liver. (Prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.)
• Active infection, ascites, hepatic encephalopathy
• Prior oxaliplatin or cisplatin or HAI FUDR
• Female patients who are pregnant or lactating

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of Medicine and Dentistry of New Jersey: collaborator

Study Sites (2)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Folfox protocol; Dexamethasone; Floxuridine; Fluorouracil; Leucovorin; Oxaliplatin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Uracil; Pyrimidinones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Nancy E. Kemeny, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

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: May 6, 2003
• First Posted: May 7, 2003
• Study Start: January 1, 2003
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (2)