Colorectal CancerPhase 2NCT00002842
Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
A Phase 2 study testing floxuridine, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- floxuridine, fluorouracil and leucovorin calcium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1994to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal carcinoma or radiologically confirmed colorectal carcinoma in a synchronous metastasis
- Intrahepatic metastases required
- No more than 15 metastases involving no more than 60% of functioning liver
- No extrahepatic disease unless:
- Resectable anastomotic or locally recurrent tumor
- Resectable mesenteric lymph node involvement in patients undergoing initial resection of primary colorectal carcinoma
- Disease extension from liver metastasis amenable to en bloc resection (e.g., diaphragm wall, kidney, abdominal wall)
- No biopsy-proven chronic active hepatitis
PATIENT CHARACTERISTICS:
Age:
- Physiologic 18 to 70
Performance status:
- Karnofsky 60%-100%
Hematopoietic:
- AGC at least 1,500
- Platelets at least 100,000
Hepatic:
- Bilirubin no greater than 2.0 mg/dL (unless reversibly obstructed by metastasis)
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- No second malignancy within 5 years except adequately treated:
- Nonmelanomatous skin cancer
- In situ bladder cancer
- In situ cervical cancer
- No pregnant women
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior mitomycin or nitrosoureas allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to the liver
- At least 3 weeks since radiotherapy and recovered
- Prior pelvic radiotherapy allowed
- No planned concurrent radiotherapy
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer.
Read the detailed description
OBJECTIVES:
- Evaluate the efficacy of hepatic resection followed by portal vein infusion of floxuridine plus systemic fluorouracil/leucovorin calcium in patients with metastatic colorectal cancer.
- Study the toxic effects of adjuvant chemotherapy following hepatic resection.
- Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of fluoropyrimidines in tumor cells, including thymidylate synthase, ribonucleotide reductase, and folylglutamyl synthetase, by polymerase chain reaction and immunohistochemistry.
OUTLINE: Following resection of the liver and all extrahepatic colorectal cancer, patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks.
If biopsy-proven metastatic disease develops, treatment may be stopped at the investigator's discretion. Continuation of regional therapy should be considered for extrahepatic failure. No concurrent radiotherapy is permitted.
Patients are followed every 3 months for 3 years, then every 6 months for survival.
PROJECTED ACCRUAL: It is expected that 50 patients will be entered over approximately 5 years.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- floxuridine, fluorouracil, leucovorin calcium, adjuvant therapy, conventional surgery
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent 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
Starting dose of 0.2 mg/kg/day for 14 consecutive days.
fluorouracilDrug
300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
adjuvant therapyProcedure or surgery
Chemotherapy given after hepatic resection
conventional surgeryProcedure or surgery
Hepatic resection
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin | Experimental | Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks Receives: Drug: floxuridine; Drug: fluorouracil; Drug: leucovorin calcium; Procedure: adjuvant therapy; Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Year Disease-free Survival .
Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.
Measured: 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1994
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lucille A. Leong, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002842
- Sponsor's protocol ID
- 94080
- Other IDs
- P30CA033572, CHNMC-IRB-94080, NCI-V96-1031, CDR0000065077
- Status last verified
- Feb 2017
- First submitted
- 1 Nov 1999
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00002842
- Acronym / sponsor ID
- 94080
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1994
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 11 Apr 2017
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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer.
Detailed description
OBJECTIVES:
- Evaluate the efficacy of hepatic resection followed by portal vein infusion of floxuridine plus systemic fluorouracil/leucovorin calcium in patients with metastatic colorectal cancer.
- Study the toxic effects of adjuvant chemotherapy following hepatic resection.
- Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of fluoropyrimidines in tumor cells, including thymidylate synthase, ribonucleotide reductase, and folylglutamyl synthetase, by polymerase chain reaction and immunohistochemistry.
OUTLINE: Following resection of the liver and all extrahepatic colorectal cancer, patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks.
If biopsy-proven metastatic disease develops, treatment may be stopped at the investigator's discretion. Continuation of regional therapy should be considered for extrahepatic failure. No concurrent radiotherapy is permitted.
Patients are followed every 3 months for 3 years, then every 6 months for survival.
PROJECTED ACCRUAL: It is expected that 50 patients will be entered over approximately 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin | Experimental | Drug: floxuridine, Drug: fluorouracil, Drug: leucovorin calcium, Procedure: adjuvant therapy, Procedure: conventional surgeryPatients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| floxuridineStarting dose of 0.2 mg/kg/day for 14 consecutive days. | Drug | Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin |
| fluorouracil300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days. | Drug | Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin |
| leucovorin calcium500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU. | Drug | Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin |
| adjuvant therapyChemotherapy given after hepatic resection | Procedure or surgery | Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin |
| conventional surgeryHepatic resection | Procedure or surgery | Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin |
Primary outcome
2 Year Disease-free Survival .
Time frame: 2 years after treatment
Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lucille A. Leong, MD study chair
City of Hope Medical Center
1 site 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, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by City of Hope Medical Center at 1 site 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
2 Year Disease-free Survival . (time frame: 2 years after treatment). 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 11 Apr 2017.