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Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies

27 november 2017 uppdaterad av: Masonic Cancer Center, University of Minnesota

Phase I Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES:

Primary

  • To determine the safety and optimal dose of hyperthermic intraperitoneal oxaliplatin when administered during cytoreductive surgery and followed by intraperitoneal leucovorin calcium and fluorouracil in patients with peritoneal malignancies.

Secondary

  • To determine the outcome of cytoreductive surgery in these patients.
  • To determine the time to disease progression and pattern of failure in patients treated with this regimen.
  • To determine the 1 and 5 year survival in patients treated with this regimen.
  • To compare quality-of-life pre- and post-surgery in these patients.
  • To characterize total- and free-platinum pharmacokinetics in the plasma and total platinum in the intraperitoneal space at baseline, during, and after hyperthermic intraperitoneal chemotherapy (HIPC).
  • To assess for the presence of genetic polymorphisms in the XDP and XRCC1 DNA repair genes.
  • To assess tumor and normal tissue concentrations for total platinum obtained at baseline and immediately after HIPC.

OUTLINE:

  • Cytoreductive Surgery: Patients undergo an exploratory laparotomy to remove all tumor nodules from all peritoneal surfaces prior to gastrointestinal anastomoses. An intraperitoneal drain is placed for postoperative intraperitoneal chemotherapy.
  • Hyperthermic peritoneal chemotherapy (HIPC): After cytoreductive surgery, but before intestinal anastomosis, patients receive oxaliplatin into the abdomen cavity at approximately 1 liter/min at 41-42º C and held for 30 minutes at the maximum tolerated dose. A heat exchanger maintains the fluid temperature at 44-46º C to maintain the intraperitoneal temperature at 41-42º C. Patients may receive fluid challenges, furosemide, mannitol, or renal dose dopamine to maintain a brisk diuresis at the discretion of the anesthesiologist.
  • Intraperitoneal chemotherapy: After HIPC, patients receive leucovorin calcium intraperitoneally through an intraperitoneal drain where it will remain for 2 hours and then drained. Patients then receive fluorouracil intraperitoneally through the intraperitoneal drain on day 1 and remain in the peritoneal fluid for 23 hours and then drained. The infusion will be repeated on day 2.

Blood samples are collected prior to surgery for pharmacogenetic studies and analyzed for the presence of genetic polymorphisms in the XPD and XRCC1 DNA repair genes and the GSTP1 and GSTM1 glutathione-S-transferase enzymes (i.e., XPD, Asp312Asn, XPD K751Q, XRCC1 Arg399GIn, XRCC1 Arg399Q, GSTP1 l105V, and GSTM1 DEL). Blood samples are also collected periodically for pharmacokinetic studies and analyzed for oxaliplatin concentrations. Normal and tumor tissue are collected periodically and analyzed for total platinum concentrations.

Quality of life is assessed at baseline and at 4, 8, and 12 months.

After completion of study treatment, patients are followed every 4 months for 2 years and then every 6 months for at least 5 years.

Studietyp

Interventionell

Inskrivning (Faktisk)

17

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • Masonic Cancer Center, University of Minnesota

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion criteria:

  • Patients must have histologic proof of peritoneal metastases (includes adenomucinosis)
  • Complete tumor resection possible (may include liver metastasis if treatable by resection or radiofrequency ablation)
  • Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose.
  • Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study.
  • Patients must have a Karnofsky performance score of ≥ 80%.

  • Adequate hematologic, renal and hepatic function within 14 days of registration defined as:

    • White blood count (WBC) ≥ 3,000
    • platelet count ≥ 70,000,
    • serum bilirubin ≤ 2.0 mg/dL,
    • serum creatinine ≤ 1.5 mg/dL
  • Patients must be at least 18 years of age
  • Patients must be able to provide informed consent

Exclusion criteria:

  • Metastatic disease is present outside the peritoneal cavity
  • Diagnosis of mesothelioma
  • Grade 2 or higher sensory neuropathy at time of study enrollment
  • History of allergic reaction to platinum compounds
  • Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study include those which are pregnancy category D - clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study therapy.
  • Previous peritoneal chemotherapy.
  • Patients with uncontrolled concurrent medical problems (i.e. diabetes mellitus) or history of uncontrolled cardiovascular disease (no history of hospitalization for acute myocardial infarction or congestive heart failure (CHF) within 3 months prior to registration).
  • Patients have psychiatric or addictive disorders that preclude obtaining informed consent.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Hyperthermic Treatment
Patients receiving combination of hyperthermic intraperitoneal chemotherapy (HIPC) with oxaliplatin plus intraperitoneal 5-Fu and intraperitoneal leucovorin with peritoneal metastases.
Läkemedel: fluorouracil
Post-operative day 1 and day 2, 600mg/m^2 intraperitoneal (IP) held for 23 hours
Andra namn:
  • 5-FU
Läkemedel: leucovorin calcium
Day 0 200 mg/m^2 intraperitoneal held for 2 hours
Läkemedel: oxaliplatin
Day 0 hyperthermic intraperitoneal oxaliplatin held for 30 minutes - assigned dose level: Levels 1 through 7 - 300 to 600 mg/m^2
Andra namn:
  • Eloxatin
Procedur: cytoreductive surgery
Day 0 Cytoreductive surgery is a systematic attempt to remove all or nearly all peritoneal nodules.
Andra namn:
  • konventionell kirurgi

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Maximum tolerated dose of hyperthermic intraperitoneal oxaliplatin
Tidsram: 30 Days Post Treatment
30 Days Post Treatment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in quality-of-life
Tidsram: Baseline and at 4, 8, and 12 months
Using the Functional Assessment of Cancer Therapy for Colorectal Cancer (FACT-C) and SF-36 (Quality of Life Evaluation in Dialysis Patients) questionnaires, the quality of life following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPC) will be reported and compared to the preoperative baseline.
Baseline and at 4, 8, and 12 months
Overall survival
Tidsram: 1 Year and 5 Years
1 Year and 5 Years
Time to Disease Progression
Tidsram: Monthly
Monthly

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Masonic Cancer Center, University of Minnesota

Utredare

  • Huvudutredare: Todd M. Tuttle, MD, Masonic Cancer Center, University of Minnesota

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2007

Primärt slutförande (Faktisk)

1 januari 2010

Avslutad studie (Faktisk)

1 september 2011

Studieregistreringsdatum

Först inskickad

27 februari 2008

Först inskickad som uppfyllde QC-kriterierna

27 februari 2008

Första postat (Uppskatta)

28 februari 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 november 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 november 2017

Senast verifierad

1 november 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2005LS068
  • 0601M79448 (Annan identifierare: IRB, University of Minnesota)

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