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Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: May 2026 to May 2027v49
  2. Primary and study completion dates: May 2025 to May 2026v48
  3. Re-verified, no change to tracked fieldsv47
  4. Primary and study completion dates: May 2024 to May 2025v46
  5. Primary and study completion dates: May 2023 to May 2024 Study sites revised (5)v45 Show all 2 changesShow less
    • Study sites revised (5)

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Show 43 earlier versionsHide 43 earlier versions
  1. Study sites revised (5)v44 Show moreShow less

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  2. Re-verified, no change to tracked fieldsv43
  3. Primary and study completion dates: May 2022 to May 2023v42
  4. Primary and study completion dates: May 2021 to May 2022v41
  5. Primary and study completion dates: May 2020 to May 2021v40
  6. Primary and study completion dates: May 2019 to May 2020v39
  7. Primary and study completion dates: May 2018 to May 2019v38
  8. Primary and study completion dates: May 2017 to May 2018v37
  9. Primary and study completion dates: May 2016 to May 2017v36
  10. Primary and study completion dates: May 2015 to May 2016 Study sites revised (5)v35 Show all 2 changesShow less
    • Study sites revised (5)

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  11. Primary and study completion dates: May 2014 to May 2015v34
  12. Primary and study completion dates: May 2013 to May 2014v33
  13. 2 versions Re-verified since Sep 19, 2012, no change to tracked fieldsv31-v32
  14. Trial status: Recruiting to Active, Not Recruiting Site details revised at 5 of 5 sitesv30 Show all 2 changesShow less
    • Site details revised at 5 of 5 sites
  15. Primary completion date: May 2010 to May 2013 Study sites: 1 to 5 · Completion date: May 2013 · Secondary endpoints: details revised at 4 of 4 entriesv29 Show all 4 changesShow less
    • Study sites: 1 to 5
    • Completion date: May 2013
    • Secondary endpoints: details revised at 4 of 4 entries
  16. Enrollment target: 49 to 64 Study description shortened, about 34 wordsv28 Show all 2 changesShow less
    • Study description shortened, about 34 words

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  17. Interventions: bevacizumab (Biological), dexamethasone (Drug), floxuridine (Drug), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin… to dexamethasone (Drug), floxuridine (Drug), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium (Drug), oxaliplatin… Eligibility criteria shortened, about 47 words · Study description shortened, about 8 words · Study title shortened, about 2 wordsv27 Show all 4 changesShow less
    • Eligibility criteria shortened, about 47 words
    • Study description shortened, about 8 words
    • Study title shortened, about 2 words

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  18. 2 versions Re-verified since Jul 7, 2009, no change to tracked fieldsv25-v26
  19. Study description expanded, about 83 words Eligibility criteria expanded, about 5 wordsv24 Show all 2 changesShow less
    • Eligibility criteria expanded, about 5 words

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  20. Site details revisedv23
  21. Interventions: bevacizumab (Drug), dexamethasone (Drug), floxuridine (Drug), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium… to bevacizumab (Biological), dexamethasone (Drug), floxuridine (Drug), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin…v22
  22. Study sites: 2 to 1v21
  23. 5 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv16-v20
  24. Study Status, Contacts/Locationsv15
  25. Re-verified, no change to tracked fieldsv14
  26. Interventions: antiangiogenesis therapy (Procedure), bevacizumab (Drug), biopsy (Procedure), chemotherapy (Procedure), conventional surgery (Procedure)… to bevacizumab (Drug), dexamethasone (Drug), floxuridine (Drug), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium… Study arms: 0 to 2v13 Show all 2 changesShow less
    • Study arms: 0 to 2
  27. 2 versions Re-verified since Apr 1, 2008, no change to tracked fieldsv11-v12
  28. Primary completion date: May 2010v10
  29. Interventions: antiangiogenesis therapy (Procedure), bevacizumab (Drug), biopsy (Procedure), chemotherapy (Procedure), conventional surgery (Procedure)… to antiangiogenesis therapy (Procedure), bevacizumab (Drug), biopsy (Procedure), chemotherapy (Procedure), conventional surgery (Procedure)…v9
  30. Interventions: antiangiogenesis therapy (Procedure), bevacizumab (Drug), biopsy (Procedure), chemotherapy (Procedure), conventional surgery (Procedure)… to antiangiogenesis therapy (Procedure), bevacizumab (Drug), biopsy (Procedure), chemotherapy (Procedure), conventional surgery (Procedure)…v8
  31. Interventions: Intervention/procedure (Procedure), anti-cytokine therapy (Procedure), antiangiogenesis therapy (Procedure), antibody therapy (Procedure)… to antiangiogenesis therapy (Procedure), bevacizumab (Drug), biopsy (Procedure), chemotherapy (Procedure), conventional surgery (Procedure)…v7
  32. Interventions: anti-cytokine therapy (Procedure), antiangiogenesis therapy (Procedure), antibody therapy (Procedure), bevacizumab (Drug), biological… to Intervention/procedure (Procedure), anti-cytokine therapy (Procedure), antiangiogenesis therapy (Procedure), antibody therapy (Procedure)…v6
  33. Study description shortened, about 2 wordsv5 Show moreShow less

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  34. 2 versions Re-verified since Aug 6, 2007, no change to tracked fieldsv3-v4
  35. Interventions: anti-cytokine therapy (Procedure), antiangiogenesis therapy (Procedure), antibody therapy (Procedure), bevacizumab (Drug), biological… to anti-cytokine therapy (Procedure), antiangiogenesis therapy (Procedure), antibody therapy (Procedure), bevacizumab (Drug), biological… Study description shortened, about 7 words · Eligibility criteria expanded, about 3 words · Study title shortened, about 2 wordsv2 Show all 4 changesShow less
    • Study description shortened, about 7 words
    • Eligibility criteria expanded, about 3 words
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver.
Trial Details
NCT Number NCT00492999
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Colorectal Cancer, Metastatic Cancer
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov