Colorectal CancerPhase 2NCT00063960
Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
A Phase 2 study testing floxuridine and irinotecan hydrochloride in people with Colorectal Cancer and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 10 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- floxuridine and irinotecan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2003to Dec 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic colorectal adenocarcinoma
- Primary colorectal adenocarcinoma that has been completely resected (R0 disease)
- No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast
- Metastatic disease
- No more than 9 liver metastases
- All lesions completely resected or completely treated by ablation (with or without resection)
- All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava
- All resected lesions must have a negative surgical margin (R0)
- Disease progression after prior systemic irinotecan for metastatic disease allowed
- No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection
- No other prior resection of extrahepatic metastases
- Must have the entire liver remnant perfused with a single catheter
- Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 mg/dL
- Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN)
- AST and ALT no greater than 2.0 times ULN
- No active hepatitis B or C infection
- No histological evidence of cirrhosis
Renal
- Creatinine no greater than 1.5 times ULN
- Calcium less than 1.3 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile
- Medically fit to begin chemotherapy between 4 and 8 weeks after surgery
- Prior cancer allowed if all of the following criteria are met:
- Undergone potentially curative therapy for all prior malignancies
- No other malignancy within the past 5 years except the following:
- Effectively treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix that has been effectively treated by surgery alone
- Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone
- No evidence of recurrence of any prior malignancy
- No prior hepatic arterial infusion pump malfunction, malperfusion, or infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunologic or biologic therapy
Chemotherapy
- No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection)
- No prior hepatic arterial infusion with fluorouracil or floxuridine
Radiotherapy
- No concurrent adjuvant radiotherapy to the pelvis
- No other concurrent radiotherapy
Other
- No other concurrent systemic therapy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7213
Central Baptist Hospital
Lexington, Kentucky, 40503-9985
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Integris Oncology Services
Oklahoma City, Oklahoma, 73112
University Medical Group
Providence, Rhode Island, 02908-4735
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: A Phase II Trial Of Toxicity Assessment In Two Cohorts Of Patients (Resection Alone Or Ablation With Or Without Resection Of Hepatic Metastases From Colorectal Cancer) Treated With Adjuvant Hepatic Arterial Infusion (HAI) FUDR Plus Systemic CPT-11
RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery.
PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.
Read the detailed description
OBJECTIVES:
- Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to any hepatic recurrence or progression in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (liver metastases resection only vs ablation with or without resection).
Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity.
Patients are followed every 3 months for 2 years.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- floxuridine, irinotecan hydrochloride
- Keywords
- stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, liver metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
floxuridineDrug
| Study group | Role | What they receive |
|---|---|---|
| floxuridine + irinotecan | Experimental | Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity.
Patients are followed every 3 months for 2 years. Receives: Drug: floxuridine; Drug: irinotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: Up to 2 years
Secondary outcomes (1)
time to hepatic recurrence or progression
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2003 (estimated)
- Study startAug 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yuman Fong, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063960
- Sponsor's protocol ID
- ACOSOG-Z05032
- Other IDs
- ACOSOG-Z05032, CDR0000305857
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2003
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of Toxicity Assessment In Two Cohorts Of Patients (Resection Alone Or Ablation With Or Without Resection Of Hepatic Metastases From Colorectal Cancer) Treated With Adjuvant Hepatic Arterial Infusion (HAI) FUDR Plus Systemic CPT-11
- ClinicalTrials.gov ID
- NCT00063960
- Acronym / sponsor ID
- ACOSOG-Z05032
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 9 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery.
PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.
Detailed description
OBJECTIVES:
- Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to any hepatic recurrence or progression in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (liver metastases resection only vs ablation with or without resection).
Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity.
Patients are followed every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| floxuridine + irinotecan | Experimental | Drug: floxuridine, Drug: irinotecan hydrochlorideWithin 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| floxuridine | Drug | floxuridine + irinotecan |
| irinotecan hydrochloride | Drug | floxuridine + irinotecan |
Primary outcome
overall survival
Time frame: Up to 2 years
1 secondary outcome
time to hepatic recurrence or progression
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuman Fong, MD study chair
Memorial Sloan Kettering Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing floxuridine and irinotecan hydrochloride in people with Colorectal Cancer and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.