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NCT01552434

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

StatusTerminated
PhasePhase 1
Primary completion
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Record History

All 35 versions: 24 with changes below, 11 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 5, 2026 Show 6 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Primary endpoints: 2 to 1
    • Sponsor's reason: < 75 % participation to \< 75 % participation
    • Enrollment target: 154 to 116
    • Secondary endpoints shortened, about 12 words
    • Publications: 2 to 3
  2. Trial terminated Sponsor's reason: < 75 % participation
    • Primary and study completion moved earlier from Oct 31, 2026 to May 8, 2026
    • Enrollment target: 155 to 154
    v34
  3. Primary and study completion dates: Mar 31, 2026 to Oct 31, 2026
    • Start date: Mar 16, 2012 to Oct 16, 2012
    v33
  4. Study Identification, Study Status, Oversight, Conditions, IPDSharingv31
  5. Study Identification, Study Status, Oversight, Conditions, IPDSharingv30
Show 18 earlier versionsHide 18 earlier versions
  1. Primary and study completion dates: Mar 31, 2024 to Mar 31, 2026v29
  2. Primary and study completion dates: Mar 31, 2023 to Mar 31, 2024v27
  3. Primary and study completion dates: Mar 31, 2022 to Mar 31, 2023v26
  4. Primary and study completion dates pushed to Mar 31, 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 216 to confirmed 155
    • Site details revised
    v25
  5. Secondary endpoints revised (2)v24
  6. Eligibility criteria expanded, about 23 wordsv23 Show 10 more changesShow less
    • Primary endpoints: 1 to 2
    • Primary completion date: Mar 2020 to Mar 31, 2020
    • Study completion date: Mar 2021 to Mar 31, 2021
    • Start date: Mar 2012 to Mar 16, 2012
    • Interventions: Bevacizumab (Drug), Cetuximab (Drug), Temsirolimus (Drug), Valproic Acid (Drug) to Bevacizumab (Biological), Cetuximab (Biological), Laboratory Biomarker Analysis (Other), Pharmacological Study (Other), Temsirolimus…
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 703 words
    • Study site revised
    • Collaborators expanded, about 4 words
    • Study title expanded, about 5 words
  7. Study completion date: Mar 2020 to Mar 2021
    • Study description shortened, about 129 words
    v22
  8. Study completion date: Mar 2020v21
  9. Study description expanded, about 257 wordsv20
  10. Study title expanded, about 14 wordsv18
  11. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v16
  12. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v15
  13. Study site revisedv13
  14. Eligibility criteria expanded, about 46 wordsv12
  15. Primary endpoint revisedv9
  16. Enrollment target: 228 to 216
    • Study description expanded, about 13 words
    v4
  17. Study description expanded, about 14 wordsv3
  18. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Sep 2020 to Mar 2020
    • Start date: Sep 2012 to Mar 2012
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Dose Limiting Toxicities (DLT)
Timeframe: First 28-day cycle

Arms and interventions

Group I (temsirolimus, bevacizumab, cetuximab)Experimental

Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22; bevacizumab IV over 30-90 minutes on days 1 and 15; and cetuximab IV over 60-120 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II (temsirolimus, bevacizumab, valproic acid)Experimental

Patients receive temsirolimus and bevacizumab as in Group I and valproic acid PO on days 1-7 and 15-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III (temsirolimus, bevacizumab)Experimental

Patients receive temsirolimus and bevacizumab as in Group I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biologicals: Bevacizumab, Cetuximab

Other: Laboratory Biomarker Analysis, Pharmacological Study

Drugs: Temsirolimus, Valproic Acid

Sites

1 site in 1 country

  • M D Anderson Cancer CenterHouston, Texas, United States