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Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma

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

Record History

The 50 most recent of 53 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Oct 2026 to Oct 2027
    • Study site revised
    v53
  2. Primary and study completion dates: Oct 2025 to Oct 2026v52
  3. Primary and study completion dates: Oct 2024 to Oct 2025v51
  4. Primary and study completion dates: Oct 2023 to Oct 2024v50
  5. Primary and study completion dates: Oct 2022 to Oct 2023v49
Show 45 earlier versionsHide 45 earlier versions
  1. Primary and study completion dates: Oct 2021 to Oct 2022v48
  2. Primary and study completion dates: Oct 2020 to Oct 2021v47
  3. Primary and study completion dates: Oct 2019 to Oct 2020v46
  4. Re-verified, no change to tracked fieldsv45
  5. Primary and study completion dates: Oct 2018 to Oct 2019v44
  6. Primary and study completion dates: Oct 2017 to Oct 2018v43
  7. Primary and study completion dates: Oct 2016 to Oct 2017v42
  8. Primary and study completion dates: Oct 2015 to Oct 2016v41
  9. Study description expanded, about 18 wordsv40
  10. Re-verified, no change to tracked fieldsv39
  11. Primary and study completion dates: Oct 2014 to Oct 2015
    • Study arms: 0 to 1
    v38
  12. Primary and study completion dates: Oct 2013 to Oct 2014v37
  13. Primary completion date: Oct 2010 to Oct 2013v36 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 61 to 65
    • Study completion date: Oct 2013
    • Eligibility criteria expanded, about 114 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 16 words
    • Site details revised
  14. Re-verified, no change to tracked fieldsv35
  15. Site details revisedv34
  16. Interventions: carboplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), dexrazoxane hydrochloride (Drug), doxorubicin hydrochloride… to carboplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), dexrazoxane hydrochloride (Drug), doxorubicin hydrochloride…v33
  17. Re-verified, no change to tracked fieldsv32
  18. Primary completion date: Oct 2009 to Oct 2010v31
  19. 2 versions Re-verified since Sep 11, 2008, no change to tracked fieldsv29-v30
  20. Interventions: carboplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), dexrazoxane hydrochloride (Drug), doxorubicin hydrochloride… to carboplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), dexrazoxane hydrochloride (Drug), doxorubicin hydrochloride…v28
  21. Re-verified, no change to tracked fieldsv27
  22. Study Status, Contacts/Locationsv26
  23. Interventions: carboplatin (Drug), cardiotoxicity attenuation (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure)… to carboplatin (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), dexrazoxane hydrochloride (Drug), doxorubicin hydrochloride…v25
  24. Re-verified, no change to tracked fieldsv24
  25. Primary completion date: Oct 2009v23
  26. Start date: Oct 2003v22
  27. Interventions: Intervention/procedure (Procedure), biological therapy (Procedure), carboplatin (Drug), cardiotoxicity attenuation (Procedure)… to carboplatin (Drug), cardiotoxicity attenuation (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure)…v21
  28. Interventions: biological therapy (Procedure), carboplatin (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure), chemotherapy… to Intervention/procedure (Procedure), biological therapy (Procedure), carboplatin (Drug), cardiotoxicity attenuation (Procedure)…v20
  29. Re-verified, no change to tracked fieldsv19
  30. Study Status, Outcome Measures, Contacts/Locationsv18
  31. Re-verified, no change to tracked fieldsv17
  32. Study Status, Eligibilityv16
  33. 2 versions Re-verified since Dec 4, 2006, no change to tracked fieldsv14-v15
  34. Enrollment target: 61
    • Study description expanded, about 12 words
    v13
  35. Re-verified, no change to tracked fieldsv12
  36. Site contact updatedv11
  37. 2 versions Re-verified since May 23, 2006, no change to tracked fieldsv9-v10
  38. Interventions: biological response modifier therapy (Procedure), carboplatin (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure)… to biological therapy (Procedure), carboplatin (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure), chemotherapy…v8
  39. Eligibility criteria shortened, about 71 words
    • Site contact updated
    v7
  40. Re-verified, no change to tracked fieldsv6
  41. Site contact updatedv5
  42. Interventions: biological response modifier therapy (Procedure), carboplatin (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure)… to biological response modifier therapy (Procedure), carboplatin (Drug), cardiotoxicity attenuation (Procedure), chemoprotection (Procedure)…v4
  • 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: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.
Trial Details
NCT Number NCT00077285
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Sarcoma
Related terms Malignant mesenchymal tumor, Rhabdomyosarcoma, Sarcoma
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov