Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma

A Phase IIa Multicenter Evaluation of The Safety And Efficacy of Weekly Administration of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment of Patients With Stage III or IV Colorectal Adenocarcinoma


Patrocinador principal: Achieve Life Sciences

Fuente Achieve Life Sciences
Resumen breve

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV colorectal adenocarcinoma.

Descripción detallada

The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.

Estado general Completed
Fecha de inicio March 2002
Fecha de Terminación September 2007
Fecha de finalización primaria September 2007
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Determine the Objective Response Rate When all patients have completed treatment
Resultado secundario
Medida Periodo de tiempo
To determine time to disease progression When all patients have completed treatment
Inscripción 28

Tipo de intervención: Drug

Nombre de intervención: S-8184 Paclitaxel Injectable Emulsion



Inclusion Criteria:

Histologic diagnosis of colorectal adenocarcinoma

Stage III or IV (Dukes's stage C or D)

One and only one prior cytotoxic chemotherapy regimen which must have included 5-FU

Adult (18 years of age or older) patients

Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)

Serum creatinine less than 2.0 mg/dL

Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values

ECOG performance status of 0 - 2

Bidimensional measurable disease

Patients who have signed an IRB / Ethics Committee approved informed consent

Life expectancy at least 12 weeks

Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)

Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

Exclusion Criteria:

Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)

Females who are pregnant or lactating

Patients with peripheral neuropathy NCI-CTC grade 2 or greater

Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry

Patients who have had an investigational agent within 4 weeks of study entry

Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Instalaciones: 5 Clinical Sites
Ubicacion Paises

Russian Federation

Fecha de verificación

June 2009

Fiesta responsable

Nombre Titulo: Monica S. Krieger, VP Regulatory Affairs

Organización: OncoGenex Pharmaceuticals

Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)