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

This study has been completed.
Sponsor:
Information provided by:
OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00034190
First received: April 23, 2002
Last updated: June 2, 2009
Last verified: June 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by OncoGenex Pharmaceuticals:

Primary Outcome Measures:
  • Determine the Objective Response Rate [ Time Frame: When all patients have completed treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine time to disease progression [ Time Frame: When all patients have completed treatment ] [ Designated as safety issue: No ]

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)
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034190

Locations
Russian Federation
5 Clinical Sites
3 Cities, Russian Federation
Sponsors and Collaborators
OncoGenex Pharmaceuticals
  More Information

No publications provided

Responsible Party: Monica S. Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00034190     History of Changes
Other Study ID Numbers: SON-8184-1066
Study First Received: April 23, 2002
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014