NCT00008294

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Cryosurgery kills cancer cells by freezing them. Combining more than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of intrahepatic and intravenous combination chemotherapy with or without cryosurgery in treating unresectable liver metastases from colorectal cancer.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

5.8 years

First QC Date

January 6, 2001

Last Update Submit

January 17, 2013

Conditions

Colorectal CancerMetastatic Cancer

Keywords

stage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectumliver metastasesrecurrent colon cancerrecurrent rectal cancer

Interventions

FOLFOX regimenDRUG
dexamethasoneDRUG
floxuridineDRUG
fluorouracilDRUG
leucovorin calciumDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum with unresectable liver metastases that comprise less than 70% of liver parenchyma * No extrahepatic disease * No ascites PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * No hepatic encephalopathy Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * No obstruction of gastrointestinal tract or genitourinary tract * No symptomatic peripheral sensory neuropathy * No active infection * No other malignancy except resectable primary colorectal carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior floxuridine * If undergoing cryosurgery (group I cryosurgery closed to accrual as of 10/13/03), must have received one of the following: * Systemic chemotherapy for metastatic disease * Adjuvant therapy within the past 6 months comprising fluorouracil with or without levamisole for resected primary colorectal carcinoma * Adjuvant therapy within the past 12 months comprising fluorouracil and leucovorin calcium with or without levamisole for resected primary colorectal carcinoma Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to liver Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

  • Kemeny N, Capanu M, D'Angelica M, Jarnagin W, Haviland D, Dematteo R, Fong Y. Phase I trial of adjuvant hepatic arterial infusion (HAI) with floxuridine (FUDR) and dexamethasone plus systemic oxaliplatin, 5-fluorouracil and leucovorin in patients with resected liver metastases from colorectal cancer. Ann Oncol. 2009 Jul;20(7):1236-41. doi: 10.1093/annonc/mdn769. Epub 2009 Feb 20.

    PMID: 19233901RESULT

  • Kemeny N, Jarnagin W, Paty P, Gonen M, Schwartz L, Morse M, Leonard G, D'Angelica M, DeMatteo R, Blumgart L, Fong Y. Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer. J Clin Oncol. 2005 Aug 1;23(22):4888-96. doi: 10.1200/JCO.2005.07.100. Epub 2005 Jul 11.

    PMID: 16009951RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Interventions

Folfox protocolDexamethasoneFloxuridineFluorouracilLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesUracilPyrimidinonesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • Nancy E. Kemeny, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

May 1, 2006

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)