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| Sponsor: | OncoGenex Pharmaceuticals |
|---|---|
| Information provided by: | OncoGenex Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034190 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Adenocarcinoma |
Drug: S-8184 Paclitaxel Injectable Emulsion |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 28 |
| Study Start Date: | March 2002 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
| Responsible Party: | OncoGenex Pharmaceuticals ( Monica S. Krieger, VP Regulatory Affairs ) |
| Study ID Numbers: | SON-8184-1066 |
| Study First Received: | April 23, 2002 |
| Last Updated: | June 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00034190 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Mitosis Modulators Colonic Diseases Antimitotic Agents Intestinal Diseases Rectal Diseases Pharmacologic Actions Intestinal Neoplasms |
Carcinoma Neoplasms Neoplasms by Site Digestive System Diseases Paclitaxel Therapeutic Uses Tubulin Modulators Gastrointestinal Neoplasms Adenocarcinoma Antineoplastic Agents, Phytogenic Colorectal Neoplasms Neoplasms, Glandular and Epithelial |