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Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 684 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Site details revised at 3 of 683 sites

    Study Status, Contacts/Locations, Outcome Measures (Results), Adverse Eventsv684

  2. Minor

    Study Status, References

    Re-verified, no change to tracked fields

    v683

  3. Minor

    Trial status: Active, Not Recruiting to Completed

    Study completion date changed from estimate of Dec 2017 to Jan 2018; Site details revised at 3 of 683 sites

    Study Status, Contacts/Locationsv682

  4. Notable

    Results first posted: Apr 26, 2017

    Completion date: Dec 2017; Secondary endpoints revised (3); Primary endpoint revised

    Show what changed: Secondary endpoints
    Progression-free survivalSurvival (PFS) Time to treatmentTreatment failureFailure Duration of tumorTumor responseResponse
    Show what changed: Primary endpoints
    Overall survivalSurvival

    Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv681

  5. Notable

    Primary completion date: Mar 2013 to Feb 2015

    Study Statusv680

Show 45 earlier versions

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v679

  2. Notable

    Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncology

    Enrollment target: estimated 2900 to confirmed 2334; Study sites: 685 to 683; Interventions: bevacizumab (Biological), cetuximab (Biological), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium (Drug)… to FOLFIRI (Drug), FOLFOX or (Drug), bevacizumab (Biological), cetuximab (Biological); and 4 more

    Show all 8 changes in this update
    • Notable Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncology
    • Minor Enrollment target: estimated 2900 to confirmed 2334
    • Minor Study sites: 685 to 683
    • Minor Interventions: bevacizumab (Biological), cetuximab (Biological), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium (Drug)… to FOLFIRI (Drug), FOLFOX or (Drug), bevacizumab (Biological), cetuximab (Biological)
    • Minor Eligibility criteria expanded, about 445 words
      Show what changed
      DISEASE CHARACTERISTICS: Locally Advanced or Metastatic Colorectal Cancer HistologicallyEligible patients must have histologically or cytologically confirmeddocumented adenocarcinoma of the colon or rectum. LocallyPatients must have either locally advanced (unresectable) or metastatic disease. Patients with resected primary tumors who have documented metastases are eligible. Separate histological or cytological confirmation is not required from patients with a history of colorectal cancer (previously treated by surgical resection) who have now developed radiological or clinical evidence of met [...] [...]
    • Minor Secondary endpoints: 4 to 3
      Show what changed
      Response (complete response and partial response)
    • Minor Study description shortened, about 1 word
      Show what changed
      OBJECTIVES: Primary Compare overall survival of patients with previously untreated metastatic colorectal cancer treated with cetuximab and/or bevacizumab in combination with either oxaliplatin, fluorouracil, and leucovorin calcium (FOLFOX) OR irinotecan hydrochloride, fluorouracil, and leucovorin ca [...] OUTLINE: This is a randomized, open-label, multicenter study [...] re stratified according to physician-selected chemotherapy (oxaliplatin, leucovorin calcium, and fluorouracil [FOLFOX] vs irinotecan hydrochloride, leucovorin calcium, or fluorouracil [FOLFIRI]), prior adjuvant chemotherapy (yes vs no), and [...] [...]
    • Minor Collaborators: 2 to 4
      Show what changed
      Bristol-Myers Squibb Aptuit

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv678

  3. Notable

    Primary completion date: Jun 2008 to Mar 2013

    Trial status: Recruiting to Active, Not Recruiting; Study sites: 671 to 685

    Study Status, Contacts/Locationsv677

  4. Minor

    Study sites: 665 to 671

    Study Status, Contacts/Locationsv676

  5. Minor

    Study sites: 663 to 665

    Study Status, Contacts/Locationsv675

  6. Minor

    Study sites: 657 to 663

    Study Status, Contacts/Locationsv674

  7. Minor

    Study sites: 720 to 657

    Study Status, Contacts/Locationsv673

  8. Minor

    Study sites: 721 to 720

    Study Status, Contacts/Locationsv672

  9. Minor

    Site details revised at 2 of 721 sites

    Study Status, Contacts/Locationsv671

  10. Minor

    Study sites: 720 to 721

    Study Status, Contacts/Locationsv670

  11. Minor

    Study sites: 719 to 720

    Study Status, Contacts/Locationsv669

  12. Minor

    Study sites: 720 to 719

    Study Status, Contacts/Locationsv668

  13. Minor

    Study sites: 719 to 720

    Study Status, Contacts/Locationsv667

  14. Minor

    Study sites: 715 to 719

    Study Status, Contacts/Locationsv666

  15. Minor

    Study sites: 717 to 715

    Study Status, Contacts/Locationsv665

  16. Minor

    Study sites: 716 to 717

    Study Status, Contacts/Locationsv664

  17. Minor

    Study sites revised (716)

    Show what changed: Study sites
    JohnOur R.Lady Marshof Mercy Medical Center Comprehensive Cancer Center at Washington County Hospital

    Study Status, Contacts/Locationsv663

  18. Minor

    Study sites: 714 to 716

    Study Status, Contacts/Locationsv662

  19. Minor

    Study sites: 715 to 714

    Study Status, Contacts/Locationsv661

  20. Minor

    Study sites: 714 to 715

    Study Status, Contacts/Locationsv660

  21. Minor

    Study sites: 713 to 714

    Study Status, Contacts/Locationsv659

  22. Minor

    Study sites: 715 to 713

    Study Status, Contacts/Locationsv658

  23. Minor

    Study sites: 716 to 715

    Study Status, Contacts/Locationsv657

  24. Minor

    Study sites: 718 to 716

    Study Status, Contacts/Locationsv656

  25. Minor

    Study sites: 717 to 718

    Study Status, Contacts/Locationsv655

  26. Minor

    Study sites: 715 to 717

    Study Status, Contacts/Locationsv654

  27. Minor

    Study sites: 712 to 715

    Study Status, Contacts/Locationsv653

  28. Minor

    Study sites: 710 to 712

    Study Status, Contacts/Locationsv652

  29. Minor

    Study sites: 708 to 710

    Study Status, Contacts/Locationsv651

  30. Minor

    Study sites: 704 to 708

    Study Status, Contacts/Locationsv650

  31. Minor

    Study sites: 710 to 704

    Study Status, Contacts/Locationsv649

  32. Minor

    Study sites: 718 to 710

    Study Status, Contacts/Locationsv648

  33. Minor

    Study sites: 720 to 718

    Study Status, Contacts/Locationsv647

  34. Minor

    Study sites revised (720)

    Show what changed: Study sites
    VeteransMemorial AffairsHospital MedicalCancer Center - HinesColorado Springs Clinton MemorialReid Hospital & Health Care Services UniversitySt. ofJohn's TennesseeRegional CancerHealth Institute - MemphisCenter

    Study Status, Contacts/Locationsv646

  35. Minor

    Study sites: 713 to 720

    Study Status, Contacts/Locationsv645

  36. Minor

    Study sites: 710 to 713

    Study Status, Contacts/Locationsv644

  37. Minor

    Study sites: 708 to 710

    Study Status, Contacts/Locationsv643

  38. Minor

    Study sites: 707 to 708

    Study Status, Contacts/Locationsv642

  39. Minor

    Study sites: 705 to 707

    Study Status, Contacts/Locationsv641

  40. Minor

    Study sites revised (705)

    Show what changed: Study sites
    JolietRichmond Oncology-HematologyUniversity Associates,Medical Limited - WestCenter

    Study Status, Contacts/Locationsv640

  41. Minor

    Study sites: 704 to 705

    Study Status, Contacts/Locationsv639

  42. Minor

    Study sites: 703 to 704

    Study Status, Contacts/Locationsv638

  43. Minor

    Study sites: 704 to 703

    Study Status, Contacts/Locationsv637

  44. Minor

    Study sites: 703 to 704

    Study Status, Contacts/Locationsv636

  45. Minor

    Study sites: 690 to 703

    Study Status, Contacts/Locationsv635

  • 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.
PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.
Trial Details
NCT Number NCT00265850
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), SWOG Cancer Research Network, Bristol-Myers Squibb, Aptuit
Conditions Colorectal Cancer
Enrollment 2,334 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov