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

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Record History

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  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 43 earlier versionsHide 43 earlier versions
  1. Study sites revised (5)v44
  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
  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 sites
    v30
  15. Primary completion date: May 2010 to May 2013
    • Study sites: 1 to 5
    • Study completion date: May 2013
    • Secondary endpoints: details revised at 4 of 4 entries
    v29
  16. Enrollment target: 49 to 64
    • Study description shortened, about 34 words
    v28
  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 words
    v27
  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 words
    v24
  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 2
    v13
  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
  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 words
    v2
  1. Study First Submitted
  • 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
(from sponsor)		 Colorectal Cancer, Metastatic Cancer
Related terms Colonic Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Rectal Neoplasms
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov