Colorectal CancerPhase 2NCT00019786
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
A Phase 2 study testing isolated perfusion, melphalan and conventional surgery in people with Colorectal Cancer and Islet Cell Tumor, run by National Institutes of Health Clinical Center (CC) 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. Giving drugs in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Islet Cell Tumor, Liver Cancer
- What is being tested?
- isolated perfusion, melphalan and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Jan 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven liver cancer meeting 1 of the following criteria:
- Primary unresectable hepatocellular or cholangiocellular carcinoma
- Metastatic cancer to the liver originating from one of the following:
- Intraocular melanoma (closed to accrual as of 10/17/03)
- Islet cell carcinoma
- Adenocarcinoma of the colon or rectum limited to parenchyma of the liver
- No evidence of other unresectable extrahepatic colorectal metastasis
- Other neuroendocrine tumors, such as carcinoid tumors
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Hematocrit greater than 27.0%
- WBC at least 2,500/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
- PT no greater than 2 seconds above upper limit of normal
- Elevated SGOT and SGPT allowed if not due to hepatitis
- No biopsy-proven cirrhosis or evidence of significant portal hypertension
- No prior or concurrent veno-occlusive disease
- Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Congestive heart failure allowed if LVEF ≥ 40%
Pulmonary:
- No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age
Other:
- Weight greater than 30 kg
- Not pregnant or nursing
- Negative pregnancy test
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 month since prior anticancer biologic therapy and recovered
Chemotherapy:
- At least 1 month since prior anticancer chemotherapy and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 1 month since prior anticancer radiotherapy and recovered
Surgery:
- Not specified
Other:
- Prior intrahepatic arterial infusion therapy allowed
- No chronic use of anticoagulants
- No concurrent immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.
Read the detailed description
OBJECTIVES:
- Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression.
PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.
- Conditions
- Colorectal Cancer, Islet Cell Tumor, Liver Cancer, Metastatic Cancer, Neuroendocrine Carcinoma
- Being tested
- isolated perfusion, melphalan, conventional surgery
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, recurrent islet cell carcinoma, adult primary hepatocellular carcinoma, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases, adult primary cholangiocellular carcinoma, advanced adult primary liver cancer, recurrent childhood liver cancer, childhood hepatocellular carcinoma, stage III childhood liver cancer, stage IV childhood liver cancer, neuroendocrine carcinoma
- Medical subject headings
- Colorectal Neoplasms, Adenoma, Islet Cell, Liver Neoplasms, Neoplasm Metastasis, Carcinoma, Neuroendocrine, Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolated perfusionDrug
melphalanDrug
conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Duration of response
Patterns of recurrence
Disease-free survival
Overall survival
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 startAug 1999
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- H. Richard Alexander, MD, FACS, Study chair, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019786
- Sponsor's protocol ID
- 990123
- Other IDs
- 99-C-0123, CDR0000067220
- Status last verified
- Mar 2012
- First submitted
- 11 Jul 2001
- Last updated
- 23 Mar 2012
- Results posted
- No
Publications
Feldman AL, Libutti SK, Pingpank JF, Bartlett DL, Beresnev TH, Mavroukakis SM, Steinberg SM, Liewehr DJ, Kleiner DE, Alexander HR. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003 Dec 15;21(24):4560-7. doi: 10.1200/JCO.2003.04.150.
PubMed 14673042
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
- ClinicalTrials.gov ID
- NCT00019786
- Acronym / sponsor ID
- 990123
- Conditions
- Colorectal Cancer, Islet Cell Tumor, Liver Cancer, Metastatic Cancer, Neuroendocrine Carcinoma
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, recurrent islet cell carcinoma, adult primary hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1999
- Study completion
- Jan 2006 (actual)
- First posted
- 27 Jan 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 use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.
Detailed description
OBJECTIVES:
- Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression.
PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| isolated perfusion | Drug | – |
| melphalan | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Response rate
Duration of response
Patterns of recurrence
Disease-free survival
Overall survival
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 23 Mar 2012.
- Results publication: PubMed 14673042Feldman AL, Libutti SK, Pingpank JF, Bartlett DL, Beresnev TH, Mavroukakis SM, Steinberg SM, Liewehr DJ, Kleiner DE, Alexander HR. Analysis of factors associated with outcome in patients with malignant peritoneal mesothelioma undergoing surgical debulking and intraperitoneal chemotherapy. J Clin Oncol. 2003 Dec 15;21(24):4560-7. doi: 10.1200/JCO.2003.04.150.
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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.
H. Richard Alexander, MD, FACS study chair
NCI - Surgery Branch
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 isolated perfusion, melphalan and conventional surgery in people with Colorectal Cancer and Islet Cell Tumor, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2012. 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?
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?
Response rate. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00019786, which also lists 1 linked publication.
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 23 Mar 2012.