title: A Phase I Trial of High-Dose Chemotherapy Combining Topotecan plus Cyclophosphamide with Hematopoietic Stem Cell Transplantation for Ovarian Cancer: The ITOV 01bis Study.
abstract: BACKGROUND
  Dose-intensive chemotherapy with hematopoietic stem cell transplantation has been evaluated as a salvage treatment for recurrent ovarian cancer, but its benefit has not yet been demonstrated. In a previous phase I trial, we reported the feasibility of administering topotecan as a salvage regimen.
  
  
  METHODS
  Twenty-one patients were treated with escalating doses of topotecan associated with a fixed dose of cyclophosphamide.
  
  
  RESULTS
  The maximum tolerated dose was established at 9.0 mg/m2 on a 5-day regimen, analogously to what was reported for topotecan monotherapy. One toxic death from septic shock and multiorgan failure occurred. Although hematopoietic toxicities were overcome by peripheral blood stem cell transplantation, superior nonhematological toxicities were observed as compared to the initial trial.
  
  
  CONCLUSIONS
  Response rates were generally short and survival rates were poor. Results of the ITOV 01bis study demonstrate that, in the setting of recurrent ovarian cancer, intensive chemotherapy based on topotecan-cyclophosphamide association is not currently clinically indicated.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Selle
authors.forename: Patricia
authors.initials: P
authors.lastname: Pautier
authors.forename: Catherine
authors.initials: C
authors.lastname: Lhommé
authors.forename: Patrice
authors.initials: P
authors.lastname: Viens
authors.forename: Michel
authors.initials: M
authors.lastname: Fabbro
authors.forename: François
authors.initials: F
authors.lastname: Lokiec
authors.forename: Joseph
authors.initials: J
authors.lastname: Gligorov
authors.forename: Sandrine
authors.initials: S
authors.lastname: Richard
authors.forename: Stéphane
authors.initials: S
authors.lastname: Provent
authors.forename: Daniele G
authors.initials: DG
authors.lastname: Soares
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lotz
mesh_terms: D018262:Adenocarcinoma, Clear Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D002288:Adenocarcinoma, Mucinous / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015331:Cohort Studies; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D018284:Cystadenocarcinoma, Serous / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016889:Endometrial Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D019772:Topotecan; D003520:Cyclophosphamide