Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]

CompletadoFase 3ClinicalTrials.gov

ID: NCT00057720Tipo: INTERVENTIONALInicio: 1 de jun de 2003Fin estimado: 1 de dic de 2006

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Resumen

The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin
Considered platinum refractory or resistant according to standard criteria
Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
Measurable disease according to RECIST criteria with documented tumor progression

Criterios de exclusión

Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin
History of whole pelvis radiation therapy within 12 months of enrollment
Clinically significant cardiac disease
Evidence of gross hematuria at the time of study entry
Any signs of intestinal obstruction interfering with nutrition at the time of study entry
Pregnant or lactating women

Intervenciones

drug

TLK286 HCl for injection

drug

topotecan hydrochloride for injection

drug

doxorubicin HCl liposome injection