Liver CancerPhase 2NCT00003044
Chemotherapy in Treating Patients With Liver Cancer
A Phase 2 study testing cisplatin-e therapeutic implant in people with Liver Cancer, run by Matrix Pharmaceutical at 3 sites in 2 countries.
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: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- cisplatin-e therapeutic implant
- How many people
- 55 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 1996to not given
- 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 proven unresectable primary hepatocellular carcinoma No major vessel involvement Disease must be confined to the liver (no extrahepatic disease) Patients have no more than 3 tumors, with no tumor exceeding 7 cm in diameter, and the sum total tumor volume less than 200 cm3
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 40-100% Life Expectancy: At least 4 months Hematopoietic: Hemoglobin at least 10 g/dL Platelet count at least 75,000/mm3 Absolute granulocyte count at least 1,000/mm3 PT within 3 seconds of institutional norm Hepatic: SGPT no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Child-Pugh grade A or B Albumin at least 25 g/L Bilirubin no greater than 2.98 mg/dL Absent or easily controlled ascites not requiring routine or intermittent paracentesis Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.3 times ULN OR Creatinine clearance at least 45 mL/min Cardiovascular: No coronary artery disease No New York Heart Association class III or greater cardiac symptoms Other: Not pregnant or nursing No medical or psychiatric condition compromising informed consent No obesity or tumor location that would limit adequate tumor imaging No history of bleeding from liver tumor(s) or gastroesophageal bleeding No known hypersensitivity to cisplatin, bovine collagen, epinephrine, sulfites or radiographic contrast agents No history of encephalopathy
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for hepatocellular carcinoma No concurrent immunomodulating agents Chemotherapy: No prior or concurrent chemotherapy for hepatocellular carcinoma No concurrent cytotoxic agents Endocrine therapy: No prior endocrine therapy for hepatocellular carcinoma Radiotherapy: No prior radiotherapy for hepatocellular carcinoma Surgery: Prior surgical resection of the liver allowed Other: No concurrent use of aspirin, nonsteroidal anti-inflammatory agents, anticoagulants including warfarin sodium (Coumadin), and epinephrine containing medications including topical anesthetics such as bupivacaine HCl No prior investigational agents within 4 weeks of study No concurrent use of probenecid or thiazides Concurrent use of analgesics and antiemetics is allowed Concurrent use of topical and other local anesthetics, locoregional nerve blocks, and systemic agents is allowed
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: A Two-Stage Phase II Safety and Efficacy Study of IntraDose (Cisplatin/Epinephrine) Injectable Gel (MPI 5010) Administered to Patients With Unresectable Primary Hepatocellular Carcinoma
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: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery.
Read the detailed description
OBJECTIVES: I. Evaluate the safety and efficacy of cisplatin-epinephrine injectable gel (Intradose MPI-5010) in patients with unresectable primary hepatocellular carcinoma.
OUTLINE: This is an open label, two stage, multicenter study. Patients receive intratumoral treatment with ciplatin-epinephrine (MPI-5010) once weekly, for up to four treatments within a six week period, followed by an evaluation two weeks after last treatment. Immediately after the first course, an optional second course of treatment may be undertaken at the discretion of the investigator. Patients with a complete response, partial response, and/or an increase in necrosis of at least 30% of total treated tumor volume will be followed monthly for up to 6 months. At the completion of 6 months follow up or following documentation of disease progression or development of new tumors, patients are monitored for survival in an extended follow up period. All nonresponders at the last 2 week posttreatment evaluation are entered in the extended follow up and monitored monthly for survival.
PROJECTED ACCRUAL: Up to 55 patients will be accrued for this study.
- Conditions
- Liver Cancer
- Being tested
- cisplatin-e therapeutic implant
- Keywords
- localized unresectable adult primary liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin-e therapeutic implantDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2004 (estimated)
- Study startSep 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matrix Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard D. Leavitt, MD, Study chair, Matrix Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003044
- Sponsor's protocol ID
- CDR0000065675
- Other IDs
- MP-417-96-2, NCI-V97-1290
- Status last verified
- Apr 2000
- First submitted
- 1 Nov 1999
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Stage Phase II Safety and Efficacy Study of IntraDose (Cisplatin/Epinephrine) Injectable Gel (MPI 5010) Administered to Patients With Unresectable Primary Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00003044
- Acronym / sponsor ID
- CDR0000065675
- Conditions
- Liver Cancer
- Keywords
- localized unresectable adult primary liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Matrix PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Sep 1996
- First posted
- 12 Aug 2004 (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: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery.
Detailed description
OBJECTIVES: I. Evaluate the safety and efficacy of cisplatin-epinephrine injectable gel (Intradose MPI-5010) in patients with unresectable primary hepatocellular carcinoma.
OUTLINE: This is an open label, two stage, multicenter study. Patients receive intratumoral treatment with ciplatin-epinephrine (MPI-5010) once weekly, for up to four treatments within a six week period, followed by an evaluation two weeks after last treatment. Immediately after the first course, an optional second course of treatment may be undertaken at the discretion of the investigator. Patients with a complete response, partial response, and/or an increase in necrosis of at least 30% of total treated tumor volume will be followed monthly for up to 6 months. At the completion of 6 months follow up or following documentation of disease progression or development of new tumors, patients are monitored for survival in an extended follow up period. All nonresponders at the last 2 week posttreatment evaluation are entered in the extended follow up and monitored monthly for survival.
PROJECTED ACCRUAL: Up to 55 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| cisplatin-e therapeutic implant | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Richard D. Leavitt, MD study chair
Matrix Pharmaceutical
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin-e therapeutic implant in people with Liver Cancer, run by Matrix Pharmaceutical at 3 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Hong Kong. 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?
Results are not available in the source record.
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.
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 19 Dec 2013.