Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer

StatusCompleted
PhasePhase 1/2
Started

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Record History

The 50 most recent of 267 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Mar 31, 2023, no change to tracked fieldsv266-v267
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date: Aug 20, 2015
    v265
  3. 4 versions Re-verified since Jan 20, 2020, no change to tracked fieldsv261-v264
  4. Interventions: Carboplatin (Drug), Cisplatin (Drug), Etoposide (Drug), Laboratory Biomarker Analysis (Other), Placebo (Other), Sunitinib Malate (Drug) to Carboplatin (Drug), Cisplatin (Drug), Etoposide (Drug), Laboratory Biomarker Analysis (Other), Placebo Administration (Other), Sunitinib…v260
  5. 8 versions Re-verified since Apr 8, 2019, no change to tracked fieldsv252-v259
Show 34 earlier versionsHide 34 earlier versions
  1. Study sites revised (125)v251
  2. 2 versions Re-verified since Feb 5, 2019, no change to tracked fieldsv249-v250
  3. Study sites revised (125)v248
  4. 3 versions Re-verified since Jul 16, 2018, no change to tracked fieldsv245-v247
  5. Study sites: 118 to 125
    • Primary completion date: Jun 2013 to Jun 30, 2013
    • Start date: Mar 2007 to Mar 15, 2007
    • Interventions: carboplatin (Drug), cisplatin (Drug), etoposide (Drug), laboratory biomarker analysis (Other), placebo (Other), sunitinib malate (Drug) to Carboplatin (Drug), Cisplatin (Drug), Etoposide (Drug), Laboratory Biomarker Analysis (Other), Placebo (Other), Sunitinib Malate (Drug)
    v244
  6. 2 versions Re-verified since May 26, 2016, no change to tracked fieldsv242-v243
  7. Results first posted: Apr 14, 2015
    • Primary endpoints: 1 to 2
    • Secondary endpoints: 3 to 2
    v241
  8. Primary endpoints: 2 to 1v240 Show 5 more changesShow less
    • Enrollment target: 141 to 156
    • Study sites: 117 to 118
    • Eligibility criteria expanded, about 187 words
    • Secondary endpoints: 6 to 3
    • Study description shortened, about 38 words
  9. Enrollment target: estimated 136 to confirmed 141
    • Study sites revised (117)
    v239
  10. Primary completion date changed from estimate of Dec 2013 to Jun 2013v238
  11. Study sites revised (117)v237
  12. Primary completion date: Jun 2013 to Dec 2013v236
  13. Secondary endpoints: 7 to 6
    • Study description shortened, about 14 words
    • Study title expanded, about 1 word
    v235
  14. Study sites revised (117)v234
  15. Primary completion date: Dec 2011 to Jun 2013
    • Trial status: Completed to Active, Not Recruiting
    v233
  16. Lead sponsor: Cancer and Leukemia Group B to National Cancer Institute (NCI)v232 Show 10 more changesShow less
    • Primary endpoints: 3 to 2
    • Trial status: Active, Not Recruiting to Completed
    • Study sites: 108 to 117
    • Primary completion date changed from estimate of Jun 2013 to Dec 2011
    • Interventions: carboplatin (Drug), cisplatin (Drug), etoposide (Drug), sunitinib malate (Drug) to carboplatin (Drug), cisplatin (Drug), etoposide (Drug), laboratory biomarker analysis (Other), placebo (Other), sunitinib malate (Drug)
    • Secondary endpoints: 4 to 7
    • Study arms: 0 to 2
    • Eligibility criteria shortened, about 5 words
    • Study description shortened, about 5 words
    • Collaborators shortened, about 4 words
  17. Primary completion date: Nov 2011 to Jun 2013
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (108)
    v231
  18. Re-verified, no change to tracked fieldsv230
  19. Site contacts updated at 3 of 108 sitesv229
  20. Re-verified, no change to tracked fieldsv228
  21. Study sites: 107 to 108v227
  22. Study sites: 108 to 107v226
  23. Study sites: 107 to 108v225
  24. Study sites: 108 to 107v224
  25. Study sites: 107 to 108v223
  26. Study sites: 108 to 107v222
  27. Study sites: 107 to 108v221
  28. Study sites: 108 to 107v220
  29. Study sites: 107 to 108v219
  30. Study sites: 26 to 107v218
  • 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.
This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating small cell lung cancer.
Trial Details
NCT Number NCT00453154
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Extensive Stage Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma
Related terms Small Cell Lung Carcinoma
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov