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Unresectable Colorectal Liver MetastasesPhase 1NCT01042691

Isolated Liver Perfusion With Oxaliplatin

A Phase 1 study testing Oxaliplatin in people with Unresectable Colorectal Liver Metastases, run by David Bartlett at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary goal of this research study is to determine a safe dose for the drug oxaliplatin when delivered by isolated hepatic perfusion. The second goal of this research study is to determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard hepatic arterial infusional (HAI) therapy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Colorectal Liver Metastases
What is being tested?
Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesUnited States
Study dates
May 2003to Nov 2011
Phase
Phase 1
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

Who may be able to join

  • Patients will be included that are scheduled to undergo surgery for placement of hepatic arterial infusion pump for HAI therapy and
  • Histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies. Limited resectable extrahepatic disease is acceptable.
  • No chemotherapy, radiotherapy, or biologic therapy for their malignancy in the 4 weeks prior to the liver perfusion and must have recovered from all side effects.
  • An ECOG performance standard of 0, 1 or 2 for 24 hours prior to surgery.
  • Adequate hepatic function as evidenced by bilirubin < 2.0 mg/dL and a PT < 2 seconds greater than the upper limit of normal.
  • Age equal to 18 years or older and greater than 30 kg.
Show all 9Show fewer
  • Platelet counts greater than 100,000, a hematocrit > 27.0, a white blood count > 3000/microliter, and a creatinine less than or equal to 1.5 mg/dL or a creatinine clearance of > 60 mL/min. Patients with elevations in hepatic transaminases secondary to the presence of metastatic disease in the liver are eligible.
  • Aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks and willing to sign an informed consent.
  • The disease in the liver must be considered unresectable as defined by greater than three sites of disease in the liver, bilobar disease, and tumor abutting major vascular or ductal structures making anatomic resection with preservation of liver function impossible.

Who cannot join

  • Pregnant patients and nursing mothers will be excluded due to the unknown effects of oxaliplatin on the fetus or newborn
  • Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible.
  • Patients with active infections are not eligible.
  • Patients with biopsy proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices on endoscopy, or radiologic studies showing significant collateral vessels around the organs drained by the portal venous system will be excluded.
  • Patients with ischemic cardiac disease or history of congestive heart failure with an LVEF < 40% will be excluded.
  • Patients with COPD or other chronic pulmonary disease with PFT's indicating an FEV< 50% predicted for age will be excluded.
  • Patients with a history of veno-occlusive disease of the liver are ineligible.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Centers, Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Shadyside

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Phase I Trial of Isolated Hepatic Perfusion With Oxaliplatin Followed by Hepatic Arterial Infusion of FUDR and Leucovorin for Patients With Unresectable Colorectal Liver Metastases

The primary goal of this research study is to determine a safe dose for the drug oxaliplatin when delivered by isolated hepatic perfusion. The second goal of this research study is to determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard hepatic arterial infusional (HAI) therapy with floxuridine (FUDR)/leucovorin.

Being tested
Oxaliplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    The starting dose of oxaliplatin administered via isolated hepatic perfusion will be the safe tolerated dose of intra-arterial infusion and pharmacokinetics from intravenous studies. The dose will be 5 mg/m2 and will be escalated.

Study groups in NCT01042691
Study groupRoleWhat they receive
OxaliplatinExperimentalSubjects who are planning to undergo surgery for placement of HAI therapy pump will be considered for enrollment. Standard HAI therapy requires a laparotomy and placement of an intrahepatic arterial catheter that is connected to one of several commercially available subcutaneous electronic pumps. The pump is then used to deliver FUDR and Leucovorin directly to the liver, usually beginning four weeks after surgery and lasts on average for a period of six to twelve months after the study. This study will examine the addition of a one hour isolated hepatic perfusion with oxaliplatin to this standard treatment
Receives: Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose and dose limiting toxicity of oxaliplatin delivered via isolated hepatic perfusion (IHP).

    Measured: 12 months

Secondary outcomes (2)

  1. To determine if isolated hepatic perfusion with oxaliplatin can increase the response rate, duration of response and survival of patients being treated with standard HAI with FUDR when compared to historical controls.

    Measured: 2-3 years

  2. To determine the tissue absorption of oxaliplatin in normal liver versus tumor during IHP.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2010 (estimated)
  2. Study startMay 2003
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01042691
Sponsor's protocol ID
02-135
Status last verified
Dec 2017
First submitted
4 Jan 2010
Last updated
20 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Lahr CJ, Soong SJ, Cloud G, Smith JW, Urist MM, Balch CM. A multifactorial analysis of prognostic factors in patients with liver metastases from colorectal carcinoma. J Clin Oncol. 1983 Nov;1(11):720-6. doi: 10.1200/JCO.1983.1.11.720.

    PubMed 6668490

  • Blumgart LH, Fong Y. Surgical options in the treatment of hepatic metastasis from colorectal cancer. Curr Probl Surg. 1995 May;32(5):333-421. doi: 10.1016/s0011-3840(05)80012-7.

    PubMed 7538062

  • Choti MA, Bulkley GB. Management of hepatic metastases. Liver Transpl Surg. 1999 Jan;5(1):65-80. doi: 10.1002/lt.500050113.

    PubMed 9873095

  • Bartlett DL. Treatment of patients with hepatic metastases. Cancer J. 2000 Apr;6 Suppl 2:S169-76. No abstract available.

    PubMed 10803832

  • Balch CM, Urist MM, Soong SJ, McGregor M. A prospective phase II clinical trial of continuous FUDR regional chemotherapy for colorectal metastases to the liver using a totally implantable drug infusion pump. Ann Surg. 1983 Nov;198(5):567-73. doi: 10.1097/00000658-198311000-00001.

    PubMed 6227295

  • Kemeny,M.M., S.Adak, and S.Lipsitz. 1999. Results of the intergroup [Eastern Cooperative Oncology Group (ECOG) and Southwest Oncology Group (SWOG) prospective randomized study of surgery alone versus continuous hepatic artery infusion of FuDR and continuous systemic infusion of 5FU after hepatic resection for colorectal liver metastases. Proc ASCO 18:1012.

  • Lokich JJ, Sonneborn H, Paul S, Zipoli T. Phase I study of continuous venous infusion of floxuridine (5-FUDR) chemotherapy. Cancer Treat Rep. 1983 Sep;67(9):791-3.

    PubMed 6224555

  • Alexander HR Jr, Fraker DL, Bartlett DL. Isolated limb perfusion for malignant melanoma. Semin Surg Oncol. 1996 Nov-Dec;12(6):416-28. doi: 10.1002/(SICI)1098-2388(199611/12)12:63.0.CO;2-D.

    PubMed 8914206

  • Alexander HR Jr, Bartlett DL, Libutti SK, Fraker DL, Moser T, Rosenberg SA. Isolated hepatic perfusion with tumor necrosis factor and melphalan for unresectable cancers confined to the liver. J Clin Oncol. 1998 Apr;16(4):1479-89. doi: 10.1200/JCO.1998.16.4.1479.

    PubMed 9552055

  • Bartlett DL, Libutti SK, Figg WD, Fraker DL, Alexander HR. Isolated hepatic perfusion for unresectable hepatic metastases from colorectal cancer. Surgery. 2001 Feb;129(2):176-87. doi: 10.1067/msy.2001.110365.

    PubMed 11174711

  • Raymond E, Chaney SG, Taamma A, Cvitkovic E. Oxaliplatin: a review of preclinical and clinical studies. Ann Oncol. 1998 Oct;9(10):1053-71. doi: 10.1023/a:1008213732429.

    PubMed 9834817

  • Rixe O, Ortuzar W, Alvarez M, Parker R, Reed E, Paull K, Fojo T. Oxaliplatin, tetraplatin, cisplatin, and carboplatin: spectrum of activity in drug-resistant cell lines and in the cell lines of the National Cancer Institute's Anticancer Drug Screen panel. Biochem Pharmacol. 1996 Dec 24;52(12):1855-65. doi: 10.1016/s0006-2952(97)81490-6.

    PubMed 8951344

  • Kern W, Beckert B, Lang N, Stemmler J, Beykirch M, Stein J, Goecke E, Waggershauser T, Braess J, Schalhorn A, Hiddemann W. Phase I and pharmacokinetic study of hepatic arterial infusion with oxaliplatin in combination with folinic acid and 5-fluorouracil in patients with hepatic metastases from colorectal cancer. Ann Oncol. 2001 May;12(5):599-603. doi: 10.1023/a:1011186708754.

    PubMed 11432616

  • Rietbroek RC, van de Vaart PJ, Haveman J, Blommaert FA, Geerdink A, Bakker PJ, Veenhof CH. Hyperthermia enhances the cytotoxicity and platinum-DNA adduct formation of lobaplatin and oxaliplatin in cultured SW 1573 cells. J Cancer Res Clin Oncol. 1997;123(1):6-12. doi: 10.1007/BF01212608.

    PubMed 8996534

  • Urano M, Ling CC. Thermal enhancement of melphalan and oxaliplatin cytotoxicity in vitro. Int J Hyperthermia. 2002 Jul-Aug;18(4):307-15. doi: 10.1080/02656730210123534.

    PubMed 12079586

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oxaliplatin in people with Unresectable Colorectal Liver Metastases, run by David Bartlett at 3 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?

The sponsor lists 9 inclusion and 7 exclusion criteria. 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 20 Dec 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

To determine the maximum tolerated dose and dose limiting toxicity of oxaliplatin delivered via isolated hepatic perfusion (IHP). (time frame: 12 months). 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 NCT01042691, which also lists 19 linked publications.

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 20 Dec 2017.

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